Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure

The Zoll LifeVest 4000 is a wearable defibrillator used to treat life-threatening abnormal heartbeats (arrhythmias) in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. The LifeVest continuously monitors the patient’s heart and, if a fast, life-threatening heart rhythm is detected, the device delivers a treatment (i.e. a shock) to restore the patient to a normal heart rhythm.

FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.” Failure to contact Zoll and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver therapy appropriately when needed.

Ideally, the LifeVest monitors the patient’s heart, delivering a “treatment shock” as needed to restore the patient’s heartbeat to a normal rhythm. However, FDA is aware that in certain cases the LifeVest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors. During normal operation, this fault prompts the LifeVest to display “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on the device screen. The “Message Code 102” alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.

To date, FDA is aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. According to Zoll, as of November 14, 2017, there were a total of 33,670 devices distributed, with 24,975 devices distributed in the U.S. About 0.1% of the total devices distributed have displayed Message Code 102, which should only be remedied by immediate replacement of the device.

The FDA will continue to work with Zoll to monitor LifeVest 4000 devices for any adverse events related to Message Code 102 or a failure to deliver treatment. The FDA will also continue to work with Zoll to identify a permanent solution to the Message Code 102 issue, and will keep the public informed as new information becomes available.

RECOMMENDATION:
For Health care providers –

  • Train patients prescribed use of the Zoll LifeVest 4000 on how to identify the “Call for service, Message Code 102” alert. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The alert will read “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” and will allow the patient to tap “OK” to return to normal operation.
  • Inform patients to respond to the “Call for service, Message Code 102” alert on the LifeVest 4000 screen by contacting Zoll immediately. Message Code 102 may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed. Zoll will replace the patient’s device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Reinforce initial LifeVest 4000 training, explaining that the device can display messages on the screen and play audio alerts that require the patient to take action. If Message Code 102 does not appear on the device screen, the patient should continue to use the LifeVest 4000 as prescribed, and read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

For Patients and Caregivers:

  • Contact Zoll immediately if “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” appears on your LifeVest 4000 screen. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The Message Code 102 alert will also allow you to tap “OK” to return to normal operation.
    > However, the “Call for service, Message Code 102” alert may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed.
    > Zoll will replace your device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Continue to use your LifeVest 4000 as prescribed by your physician and as instructed during your initial training if the “Call for service, Message Code 102” alert is NOT displayed on your device screen. You should continue to read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization. To date, there have been no reports of adverse events associated with this issue.

NEXTERONE is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.
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Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter – Anaphylaxis and Other Serious Hypersensitivity Reactions

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting—some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Symptoms of anaphylaxis can include wheezing or difficulty breathing, swelling of the face or throat, hives or flushing, itching; abdominal cramping, abdominal pain or vomiting, back pain or chest pain, hypotension or shock.

BACKGROUND: Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.

Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,

  1. administration of Varubi (rolapitant) injectable emulsion should be stopped immediately.
  2. appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
  3. Varubi (rolapitant) injectable emulsion should be permanently discontinued.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  1. Complete and submit the report Online: www.fda.gov/MedWatch/report
  2. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

See the Health Care Provider Letter for important prescribing information to reflect the new safety information.

Forest Service hiring for temporary positions for 2018 field season

From November 1-9, the Forest Service, U.S. Department of Agriculture, will be accepting applications for temporary spring and summer jobs in Arizona and New Mexico.

More information on temporary employment in the Forest Service’s Southwestern Region can be found at Centralized Temporary Hiring Outreach, including a link to the 2018 Outreach Notice with job listings for the Southwestern Region.

Applications must be submitted on www.USAJOBS.gov. Interested applicants are encouraged to create a profile within USAJOBS prior to the open vacancy announcement period.

Positions in the Southwestern Region of the Forest Service are available in multiple fields, including wildland fire, engineering, visitor services, archaeology, recreation management, timber management, range management, wildlife program management, business management, and other fields in natural resource management.

Positions will be filled at various locations within any of the 11 national forests in Arizona and New Mexico and the three national grasslands in New Mexico, Oklahoma, and west Texas.

To learn more about national forests and national grasslands in the agency’s Southwestern Region, please visit http://www.fs.usda.gov/r3.

The Forest Service is an equal opportunity employer. The mission of the Forest Service is to sustain the health, diversity, and productivity of the nation’s forests and grasslands to meet the needs of present and future generations.

SCA Pharmaceuticals Issues Voluntary Nationwide Recall

SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. The is a potential for the products to contain microbial contamination.

Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue, but out of an abundance of caution, is voluntarily initiating this recall.
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Infant Sleep Positioners: FDA Warning – Risk of Suffocation

ISSUE: FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach. In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.

BACKGROUND: The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

RECOMMENDATION: Parents and other caregivers should not put babies in sleep positioning products.

  • NEVER use infant sleep positioners. Using this type of product to hold an infant on his or her side or back is dangerous.
  • NEVER put pillows, blankets, loose sheets, comforters, or quilts under a baby or in a crib. These products also can be dangerous. Babies don’t need pillows and adequate clothing—instead of blankets—can keep them warm.
  • ALWAYS keep cribs and sleeping areas bare. That means you should also never put soft objects or toys in sleeping areas.
  • ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib.”

ISSUE: FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach. In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.

BACKGROUND: The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

RECOMMENDATION: Parents and other caregivers should not put babies in sleep positioning products.

NEVER use infant sleep positioners. Using this type of product to hold an infant on his or her side or back is dangerous.
NEVER put pillows, blankets, loose sheets, comforters, or quilts under a baby or in a crib. These products also can be dangerous. Babies don’t need pillows and adequate clothing—instead of blankets—can keep them warm.
ALWAYS keep cribs and sleeping areas bare. That means you should also never put soft objects or toys in sleeping areas.
ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib.”

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Williams and Tusayan Ranger Districts announce seasonal prescribed fire plans

Fire managers on the south zone of the Kaibab National Forest have completed plans for the 2017 fall and 2018 spring prescribed fire burning seasons and expect to begin working in several project areas by the end of this month. The specific units to be ignited will be chosen based on fuel moistures and weather conditions that are within prescriptive levels that meet fuels reduction objectives.

The flowing project areas are planned for treatments:

Green Base Dry Lake Project: Thirteen burn units northeast of Williams, north of I-40 and east of Highway 64 near Pittman Valley. This project is a total of 5,990 acres.

Green Base Hardy Project: Five burn units also northeast of Williams, north of I-40 and east of Highway 64 near Pittman Valley. This project is a total of 3,846 acres.

Sunflower Project: Seven burn units south of Williams, between County Road 73 and Whitehorse Lake. This project is a total of 15,195 acres.

Reed Project: Three burn units 5 miles east of Tusayan and just south of the Grand Canyon National Park. This project size is 1,182 acres.

Fire plays a beneficial role in maintaining the ecological stability of many landscapes including the Kaibab National Forest. Managers use prescribed fire as a practical means to reduce risks associated with uncharacteristic wildfires that can pose significant threats to public health and safety.

Officials understand that impacts to air quality may be unpleasant at times, however they can significantly reduce the amount and limit the duration of smoke more effectively using prescribed methods as opposed to an uncontrolled wildfire situation. Fire managers will continue to be mindful of wind direction and ventilation and will take a proactive approach to minimize smoke impacts to businesses and residences whenever possible.

During operations, fire personnel and vehicles working in the vicinity of the burns will be visible to the public. Motorists are reminded to slow down and drive with heightened caution when passing through active project areas.

All prescribed burning on the Kaibab National Forest is subject to approval by the Arizona Department of Environmental Quality.

For additional information on the Smoke Management Division of the ADEQ and to view prescribed burns authorizations, please visit www.azdeq.gov/environ/air/smoke/index.html. Additional fire information for Kaibab National Forest can be obtained through the following sources: InciWeb inciweb.nwcg.gov/incident/5160/ Kaibab National Forest Fire Information Phone Line (928) 635-8311; Text Message – text ‘follow kaibabnf’ to 40404.

Northern AZ prairie dog burrows dusted to combat plague near Williams, Flagstaff

FLAGSTAFF — The Arizona Game and Fish Department, together with the Kaibab National Forest Williams Ranger District, recently applied insecticidal dust Williams and Flagstaff-area Gunnison prairie dog holes for fleas.

Last month fleas tested near the Red Lake area north of Williams tested positive for plague, a potentially fatal disease that could eradicate prairie dog colonies and other infected animals. Plague-infected fleas were also recently found at an AZGFD research plot at Garland Prairie near Flagstaff.

“Unfortunately, it has been a very busy year for plague,” said Holly Hicks, a small mammals biologist with AZGFD. “An infestation can prove detrimental for prairie dog populations because they are highly communal animals, and the disease spreads easily in a colony. That is why it is important for us to identify an infected colony and dust it with insecticide to reduce the risk of infection to other animals and people.”

Crews recently dusted prairie dog holes across 664 acres near Red Lake about 10 miles north of Williams.

On September 3, an AZGFD biologist found a deceased prairie dog, which tested positive for plague near Garland Prairie. To prevent the spread, an additional 800 acres were dusted, including around plots currently being used for sylvatic plague vaccine research.

The disease is carried by fleas which spread the disease through host animals. While prairie dogs are host to fleas, the fleas can remain in the burrow after their host dies and attach themselves to the next host that comes along, which may or may not be another prairie dog.

Badgers, coyotes and foxes are also host to fleas and are more likely to cause a widespread outbreak of the disease because they travel further distances.

Those in areas where plague and/or rodents are known to be present are urged to take the following precautions to reduce their risk of exposure:

  • Do not handle sick or dead animals.
  • Prevent pets from roaming loose. Pets can pick up the infected fleas. De-flea pets routinely. Contact your veterinarian for specific recommendations.
  • Avoid rodent burrows and fleas.
  • Use insect repellents when visiting or working in areas where plague might be active or rodents might be present (campers, hikers, woodcutters and hunters).
  • Wear rubber gloves and other protection when cleaning and skinning wild animals.
  • Do not camp near rodent burrows and avoid sleeping directly on the ground.
  • In case of illness see your physician immediately as treatment with antibiotics is very effective.

More information is available at https://www.cdc.gov/plague/.

Officials lift closure of Kendrick Mountain area on Kaibab and Coconino National Forests

WILLIAMS – Effective at 6 p.m. Wednesday, the Kaibab and Coconino National Forests—in coordination with the Arizona Game and Fish Department—lifted the area closure on and around Kendrick Mountain that has been in place since the Boundary Fire in June. The public can now access the area, which had been closed due to unstable conditions caused by heavy monsoonal rains, but are advised to have heightened awareness about potential safety hazards and exercise increased vigilance regarding personal safety.

“Public safety was the driving factor in keeping the area closed for as long as we did,” said Kaibab National Forest Supervisor Heather Provencio. “It was important that we allow the landscape to stabilize during the immediate post-fire period and especially at the height of our monsoon season. We now believe it is appropriate to lift the closure, but that doesn’t mean that no hazards exist. It is important for people to always be aware of their surroundings when recreating in the forest, but it is especially important in areas recently impacted by wildfire.”

Potential risks in any area recently burned by wildfire include the following:

  • storms resulting in flash flooding that could wash out roads, initiate debris flows, and entrap people at flooded stream courses;
  • unsound burned trees (snags) that could fall or shed large limbs;
  • eroded and very rough roads resulting in dangerous driving conditions;
  • unstable terrain with potential for rolling debris (logs, rocks, boulders, etc.);
  • burned out stump holes that could cause injury if stepped in;
    and, blowing dust on roads and hillsides.

Visitors to the Kendrick Mountain area are advised to follow these outdoor safety best practices:

  1. Know the weather forecast and check it frequently as conditions can change in a very short timeframe.
  2. Let someone outside of the area know exactly where you are and where you will be going daily.
  3. Do not park vehicles or camp in areas with burned snags or where potential flood waters would prevent escape. Know where you are in relation to drainages.
  4. During windy conditions, remain in open areas that are free of trees (both live and burned) as much as possible.
  5. If an area seems unsafe for any reason, leave.
  6. Have good maps and know where you are at all times.
  7. Keep a well-charged cell phone with you and check it frequently so you know when you’re in an area where there is no coverage.
  8. Understand that there are many areas on public lands that are remote. It can take a very long time before responders can arrive if a rescue is required. The Kendrick Mountain area is very remote.

Visitors to the Kendrick Mountain area should also be aware that Forest Road 149 on the Kaibab National Forest side and which leads to the Pumpkin Trailhead is undergoing maintenance work for at least the next week. Barricades are installed at the entry to the road, so Pumpkin Trail users will have to park along Forest Road 171 and then walk to the trailhead, which will add about a mile to overall hiking distance. No driving or parking along Forest Road 149 will be allowed until the road maintenance work has been completed and the barricades removed.

The Kaibab and Coconino National Forests have been coordinating closely with the Arizona Game and Fish Department on the lifting of the Kendrick Mountain area closure due to several big game hunts opening in northern Arizona. The mountain is part of Game Management Unit 7W, and there are many hunters planning trips to the area in the coming weeks.

“We urge hunters to understand the potential hazards and to prepare accordingly,” said Colby Walton, wildlife manager with the Arizona Game and Fish Department. “We know people wait a long time for their hunts. We want them to get to have the experience, but we also want them to do it safely, recognizing that any area recently impacted by wildfire will likely have some greater risk than other areas.”

Public invited to release of California Condors on September 30, at Vermilion Cliffs National Monument

VERMILION CLIFFS – California Condors will be released to the wild in Vermilion Cliffs National Monument in northern Arizona at 11 a.m. Saturday, September 30. The public is welcome to observe the release from a viewing area where spotting scopes will be set up and project personnel will be available to answer questions.

The release coincides with National Public Lands Day, the nation’s largest hands-on volunteer effort to improve and enhance America’s public lands. National Public Lands Day involves the U.S. Bureau of Land Management and other federal agencies, along with state and local governments and private groups.

· Driving directions: Take Highway 89A from Kanab or Page to the Vermilion Cliffs (from Flagstaff take Highway 89 to Highway 89A). Turn north onto BLM Road 1065 (a dirt road next to the small house just east of the Kaibab Plateau) and continue almost 3 miles.
· Bring: Spotting scope or binoculars, sunscreen, water, snack, chair and layered clothing
· Details: Informational kiosk, shade structure, and restroom at the site.
· Map: https://www.blm.gov/sites/blm.gov/files/documents/files/2010%20VCNM%20California%20Condor%20Release%20Map.pdf

This will be the 21st annual public release of condors in Arizona since the condor recovery program began in 1996. Condors are hatched and reared in captivity at The Peregrine Fund’s World Center for Birds of Prey in Boise, Idaho, and transported to Arizona for release to the wild. Condors also come to the release site from the Oregon Zoo, Los Angeles Zoo, and San Diego Zoo Safari Park.

As of June 30, there were 74 condors in the wild in the rugged canyon country of northern Arizona and southern Utah. The world’s total population of endangered California Condors numbers over 450 individuals, with more than half flying in the wilds of Arizona, Utah, California, and Mexico. The historical California Condor population declined to just 22 individuals in the 1980s when the program was initiated to save the species from extinction.

The Arizona-Utah recovery effort is a cooperative program by federal, state, and private partners, including The Peregrine Fund, Arizona Game and Fish Department, U.S. Fish and Wildlife Service, the Bureau of Land Management’s Vermilion Cliffs National Monument, Grand Canyon and Zion national parks, Utah Division of Wildlife Resources, and Kaibab and Dixie national forests among many other supporting groups and individuals.

For more information about California Condors in Arizona: http://www.peregrinefund.org/condor