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.

Pile Burning continues on Williams Ranger District

Kaibab Forest Service photo

WILLIAMS – Conditions remain optimal for fire managers to continue burning slash piles on the south side of the Williams Ranger District and crews will move forward with burning an additional 94 acres on Thursday of this week near Coleman Lake adjacent to County Road 73. As moisture in the area remains, additional acres will be identified and treated.

Recent snow fall levels have allowed for the opportunity to work at least two more days in the area. Fuels specialists are accomplishing the objectives they hoped for with no control concerns. Pile burning will likely continue throughout the winter months as weather permits and conditions remain favorable.

Smoke may be visible during the early part of the day but is expected to be minimal in volume and disperse rapidly. No overnight impacts are expected.

Visitors are always reminded to use caution when traveling in the vicinity of prescribed fires, as firefighters, fire-related traffic and smoke may all be present.

All prescribed fires are subject to approval by the Arizona Department of Environmental Quality. For additional information on the Smoke Management Division and to view prescribed burn authorizations for any given day, visit www.azdeq.gov/programs/air-quality-programs/smoke-management

Notifications of upcoming prescribed fires are provided regularly throughout the year. This information can be found at the following sources:

· Fire Information Recorded Hotline: 928-635-8311
· Twitter: www.twitter.com/KaibabNF (Text ‘follow kaibabnf’ to 40404 to receive text messages.)
· Kaibab Facebook: www.facebook.com/KaibabNF
· Kaibab website “Recent News”: www.fs.usda.gov/kaibab
· Kaibab South Zone Rx Fire: inciweb.nwcg.gov/incident/5160/

Snowfall forecast on North Kaibab Ranger District

FREDONIA – Fire managers plan to burn piles on the North Kaibab Ranger District of the Kaibab National Forest tomorrow through Friday, weather permitting.

Crews will be active on approximately 125 acres at the southern end of the district near DeMotte campground and on 250 acres at the northern end of the district near Jacob Lake. The treatment is continuation of the Plateau Facilities Fire Protection Project, an ongoing wildfire mitigation project that includes a combination of prescribed burning and mechanical thinning designed to ultimately treat about 5,000 acres across the Kaibab Plateau.

The piles have cured over the last few years and are expected to consume quickly. Winds are expected to have a southerly influence, which would push any smoke produced to the north/northeast. However, fire managers anticipate smoke impacts to be very light as transport winds are forecast to be 10-to-15 mph. Individuals in the surrounding area who have smoke sensitivities are advised to limit their outdoor exposure during the pile burn.

General Information: Implementation of any particular prescribed fire, including a pile burn, is dependent on weather and fuel conditions including winds, temperature, humidity, moisture of the vegetation and ventilation conditions for dispersal of smoke. All prescribed fires are subject to approval by the Arizona Department of Environmental Quality. For additional information on the Smoke Management Division and to view prescribed burn authorizations for any given day, visit http://www.azdeq.gov/programs/air-quality-programs/smoke-management.

No road or trail closures are expected. However, in the interest of safety, visitors are always reminded to use caution when traveling in the vicinity of prescribed fires, as firefighters, fire-related traffic, and smoke may all be present.

Williams Ranger District plans small pile burns on Wednesday

WILLIAMS – Fire managers on the Williams Ranger District are planning to burn two small units of slash piles totaling 16 acres on Wednesday of this week. A 2 acre unit of machine piles on the southwest side of Sitgreaves Mountain and a 14 acre block of hand piles near forest road 108 south of I-40 are the specific locations scheduled for treatment.

“Conditions are ideal for cleaning up these two areas with the impending weather forecast bringing snow overnight” said Fuels Specialist Zach Boness. “We expect full consumption of the debris with no potential for fire to carry on the ground.”

Smoke is expected to rise just above tree top levels and disperse rapidly to the east moving away from the local area. Short duration smoke impacts may occur on County Road 73, and on the south side of the district throughout the day however no overnight impacts are expected.

Visitors are always reminded to use caution when traveling in the vicinity of prescribed fires, as firefighters, fire-related traffic and smoke may all be present.

All prescribed fires are subject to approval by the Arizona Department of Environmental Quality. For additional information on the Smoke Management Division and to view prescribed burn authorizations for any given day, visit www.azdeq.gov/programs/air-quality-programs/smoke-management

North Kaibab Ranger District scheduled to close due to construction

FREDONIA – All services at the North Kaibab Ranger District office will be closed on Tuesday, December 12 and Wednesday, December 13 due to the construction of a pedestrian boardwalk and hazardous tree removal of the large Elm directly west of the main building.

Services are scheduled to resume on Thursday, December 14 Monday through Friday, excluding holidays. Regular office hours are 8 a.m. to 4:30 p.m.

Kaibab National Forest partners with The Nature Conservancy on forest restoration project

Heavy equipment being used during mechanical thinning operations along Forest Road 122. Photo by Dyan Bone. Credit Kaibab National Forest.

WILLIAMS – The Kaibab National Forest is partnering with The Nature Conservancy to complete critical forest restoration and watershed protection work around Bill Williams Mountain near the City of Williams.

The tree thinning work within the 2,496-acre Clover project area began this week and is expected to continue over the next two years, depending on weather and ground conditions at any given time. The work is occurring within the larger 15,200-acre Bill Williams Mountain Restoration Project footprint and is a top treatment priority for forest managers due to the area being the primary watershed and municipal water supply for the City of Williams.

“Getting this work accomplished is incredibly important to us as forest managers and as members of the Williams community,” said Samantha Flores, timber staff officer for the South Zone of the Kaibab National Forest. “By partnering with The Nature Conservancy through a stewardship agreement, we are able to meet our shared goals of greatly improving forest and watershed health while also making the City of Williams safer in the long run from threats like wildfire and flooding.”

As thinning work is implemented, residents and visitors can expect to see heavy, mechanized equipment and workers in the project area as well as an increasing number of log trucks, including some that may need to travel through the City of Williams. Haul routes will include forest roads 111, 106 and 140 as well as County Road 73 and Interstate 40. It is possible that there could be a significant number of trucks hauling timber through the area until project completion.

Members of the public are urged to use extreme caution near timber removal and hauling operations. Besides the presence of heavy equipment and log trucks, there will also be trees being felled and stacked into log decks, which can be unstable. Visitors to the area should not camp near nor climb on them, as they often shift and have the possibility of collapse.

While there are no official closures in place associated with this forest restoration work, visitors interested in hiking Bill Williams Mountain are encouraged to use the Bill Williams Mountain Trail rather than the Benham Trail for the duration of the project due to the likelihood that temporary detours or re-routes of Benham Trail might be necessary at various points, depending on harvesting activity.

Besides the Clover project, other forest restoration efforts are also underway in the Bill Williams Mountain Restoration Project footprint. Kaibab National Forest employees have planned and laid out more than 3,500 acres to be included in timber sales. This has involved developing prescriptions for these acres and marking trees within them. Members of the public may notice the marked trees while visiting the area. The Forest Service will be seeking to offer these acres in timber sales in the near future to local contractors and others who may be able to support the forest restoration effort.

Also, 700 acres are being treated using hand thinning operations on the steep slopes of the south side of Bill Williams Mountain. Because of the inability of most heavy equipment to reach these challenging areas, crews are carrying in chainsaws to accomplish the work.

Finally, more than 200 acres are being treated using mechanical thinning, meaning heavy equipment, along Forest Road 122, also known as the Twin Springs Road, south of Bill Williams Mountain. This treatment is intended to serve as a buffer for any wildfires that might get started south of the mountain. This is a particularly important place to treat given prevailing winds in northern Arizona and the typical direction of wildfire spread due to those winds. This is also a critical treatment due to the high recreational use in this area and the resulting potential for unwanted, human-caused wildfires that could pose threats to the mountain and to the Williams community.

“For many years, even decades, on the Kaibab National Forest, we have been working toward this goal of treating Bill Williams Mountain in a truly significant way that will help not only in terms of forest health but also community protection and public safety,” said Mike Uebel, fuels program manager for the Williams Ranger District of the Kaibab National Forest and the implementation team leader for the Bill Williams Mountain Restoration Project. “To see all of the time, energy and preparation we’ve put into this effort turning into actual work on the ground is very rewarding and something we hope the Williams community will be pleased to see in action.”

Prescribed burning to continue near Tusayan

TUSAYAN – Crews plan to continue working on the Reed Prescribed Fire project east of Tusayan over the next few days and will likely begin on Friday of this week. Burning may continue into the week ahead providing weather conditions remain favorable for meeting forest health objectives and desired smoke dispersion.

Ignitions are set to continue on a 289 acre block approximately 4 miles east of Tusayan and just south of the East Rim Drive in the Grand Canyon National Park.

“The majority of smoke produced during daytime operations is expected to disperse away from sensitive areas, however we do expect some residual smoke to settle into drainages and low lying areas overnight.” said Quentin Johnson, Fire Management Officer on the Tusayan Ranger District. “Due to the proximity of these particular burn units located relatively close to town, our biggest challenge is trying to treat these acres with the least amount of smoke impact to the surrounding communities.”

Managers recognize the inconvenience smoke can cause and adjust tactics to limit the number of days smoke is in the air by burning smaller portions and only igniting every few days allowing ventilation to occur earlier and more rapidly. Among the many benefits of re-introducing fire to landscapes in these forested areas, broadcast burning is utilized to remove dead and down debris from ground surfaces over wide areas lessening the potential for a catastrophic wildfire.

Smoke may be visible from Highway 64 and from the communities of Grand Canyon, Valle and Tusayan. Overnight smoke impacts are expected to lift and ventilate rapidly each morning as ground surface temperatures warm in the morning hours.Officials remind motorists to always use caution when driving on roadways where visibility may potentially be impacted by smoke. Fire managers work closely with the Arizona Department of Environmental Quality, partners in the Grand Canyon National Park, as well as surrounding Native American tribes to monitor air quality.

For more information and the most current updates about prescribed fire on the Kaibab National Forest the following resources are available:

• Inciweb: inciweb.nwcg.gov/incident/5160/
• Fire Information Recorded Hotline: 928-635-8311
• Facebook: www.facebook.com/KaibabNF/
• Twitter: twitter.com/kaibabnf (Text ‘follow kaibabnf’ to 40404 to receive text messages.)
• Kaibab website “News & Events”: www.fs.usda.gov/kaibab

Fire managers to conduct prescribed fire southeast of Williams tomorrow

WILLIAMS – Fire managers for the South Zone of the Kaibab National Forest plan to treat up to 320 acres with prescribed fire tomorrow in the Sunflower Project area on the Williams Ranger District.

Specifically, fire managers plan to ignite the 320 acres in an area just south of Forest Road 139 and east of Hyde Hill about 8 miles southeast of the City of Williams. Ignitions should be complete by early afternoon, and fire managers do not anticipate conducting any other prescribed fires on the Williams Ranger District this week.

Smoke from tomorrow’s prescribed fire in the Sunflower Project area is expected to largely remain south of Williams and potentially impact Barney Flat and Cougar Park. It is possible that light smoke impacts may occur along County Road 73 and in Williams.

Prescribed fire projects require approval from the Arizona Department of Environmental Quality and are dependent on weather and wind conditions, so any project may be canceled if approval is not received or if conditions are not suitable. Members of the public can view approved prescribed fires for any given day on ADEQ’s website at http://www.azdeq.gov/environ/air/smoke/index.html. Prescribed fires on the Kaibab National Forest begin with the identifier “KNF.”

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

During prescribed fires, motorists are cautioned that smoke may be present for short durations, which may impact roads and populated areas. Motorists are reminded to use caution, drive slowly, turn on headlights, and avoid stopping in areas where fire personnel are working.

Notifications of upcoming prescribed fires are provided regularly by news releases throughout the season and also through the following resources:

Sign up to receive news releases from Kaibab NF: www.fs.fed.us/news/subscription.shtml (Choose “Southwestern Region.”)
Kaibab NF’s website: www.fs.usda.gov/kaibab (Look under “Recent News.”)
Kaibab NF’s Twitter account: www.twitter.com/KaibabNF (Text ‘follow kaibabnf’ to 40404 to receive text messages.)
Kaibab NF’s Facebook page: www.facebook.com/KaibabNF
Kaibab NF’s Inciweb page for the South Zone (Williams and Tusayan Ranger Districts): https://inciweb.nwcg.gov/incident/5160/#
Kaibab NF’s Inciweb page for the North Zone (North Kaibab Ranger District and North Rim of Grand Canyon National Park): https://inciweb.nwcg.gov/incident/5632/#
Kaibab NF’s Fire Information Recorded Hotline: 928-635-8311

A map of the Sunflower Project area is provided below. The map shows the entire 15,195-acre Sunflower Project. Tomorrow, fire managers plan to burn only 320 acres in the northeast corner of the larger project area just south of Forest Road 139 and east of Hyde Hill.