Category Archives: National Government

Datascope recalls certain Intra-Aortic Balloon pumps.

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Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code.

AFFECTED PRODUCT PART NUMBER
CS100i IABP 0998-UC-0446HXX; 0998-UC-0479HXX
CS100 IABP 0998-00-3013-XX; 0998-UC-3013-XX
CS300 IABP 0998-00-3023-XX; 0998-UC-3023-XX

This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.

Overall Action for User
Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices:

  • Pursuant to the USER Instruction WARNINGS, clinicians are instructed not to leave the patient unattended during IABP therapy.
  • An additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. It is important to note the following WARNING in the CS100i, CS100 or CS300 IABP Operating Instructions Manual:

    WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.

  • Until the service is performed, we recommend powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.

Datascope has received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.

There are approximately 12,000 affected units sold globally. The affected IABP units were distributed in the U.S. and worldwide (in over 100 countries). Affected units were distributed between March 23, 2003, and December 11, 2013. Units distributed after December 11, 2013, are not affected by the field correction.

A service representative from Datascope will be replacing the defective solenoid driver boards. Customers having affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service.

For additional information regarding this field correction, please contact the Customer Service Department at 1-888-627-8383 and Press 2 (Monday through Friday from 8:00 a.m. to 6:00 p.m. EDT).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

Wind shift may relieve Flagstaff of smoke from Boundary Fire

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WILLIAMS – Overnight light north winds pushed smoke into some communities around Flagstaff with most of the smoke dispersing before dawn. As Sunday progresses, northeast winds are expected to push smoke toward Williams and Bellemont. Individuals sensitive to smoke may want to stay indoors to avoid smoke impacts.

Firefighter, public safety, and ecosystem health remain the top priorities for fire managers while keeping the fire within the planning area. Smoke continues to affect Highway 180, especially at night, and may impact I-40 and SR 64 tonight. Travelers are urged to use caution when traveling in and around the fire area.

Aerial ignitions will continue today and into the week on Kendrick Mountain. Ground crews continue to conduct hand ignitions near and around private property. Ignitions will be applied slowly to prevent high intensity fire and to minimize smoke effects to communities and highways.

Kaibab National Forest (map) and Coconino National Forest have instituted Stage 1 Fire Restrictions as of June 15, 2017, at 8:00am MST.

The following trails in the closure area are closed: Pumpkin Trail, Kendrick Mountain Trail, Bull Basin Trail, Slate Mountain Trail, Kendrick Watchable Wildlife Trail, and the 4th Connector Trail. While the Red Mountain Trail is open, it can only be accessed from the valley end of the Highway 180.

Boundary Fire continues to burn fuels

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WILLIAMS – Warmer and dryer weather conditions are expected over the weekend which could slow progress on the Boundary Fire, as fire crews work slowly and methodically to back the fire down the mountain. This will allow for better control reducing the chances of the fire front pushing uphill and creating intense heat which would adversely affect the tree canopy. It is important that fire crews continue with ignitions during dry weather as it allows for consumption of the decadent fuels on the ground, decreasing the heavy accumulation of fuels on the mountain. The window of opportunity to be able to reduce fuel loads in this area is limited to the time between when the fuels dry out from winter snow melt and the Monsoon rains. Therefore, timing is everything.

Every year Kendrick Mountain sees multiple fire starts. By allowing this fire to reduce the hazardous fuels that exist there currently, we are setting ourselves, our neighbors and our communities up for less risk from those starts in the future.

Today, aerial ignitions continued adjacent to the historic cabin and Kendrick Lookout Tower. Helicopters were onsite assisting with water drops in the area. Ground crews began preforming hand ignitions near and around private property.

Expect increased smoke production over the next few days and poor air movement. Smoke may affect local communities including Greater Doney Park, Timberline, City of Flagstaff, Baderville, Fort Valley, and Bellmont. Firefighter, public safety, and ecosystem health remain the top priorities for fire managers while keeping the fire within the planning area.

Closure Order Number 04-17-14-F (PDF)) includes all or parts of Forest Roads 9005, 9023C, 91, 736, 144, 171, 193, and ending at US Highway 180 remains in effect. This closure includes all roads and trails within the perimeter of the closure area. US Highway 180 will also remain closed until further notice. For more information regarding highway closures please visit azdot.gov or visit ADOT’s Travel Information Site at www.az511.gov.

For more information on the Boundary Fire, visit inciweb.nwcg.gov/incident/5209/. Quick updates will also be provided via Twitter at @KaibabNF and @CoconinoNF. Please follow us if you would like to be updated as information is received.

Increased Smoke Production Expected While Crews Make Progress on the Boundary Fire

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WILLIAMS – Yesterday, aerial ignitions in conjunction with helicopters dropping water to moderate fire intensity of the 6278-acre Kendrick fire around the historic cabin and Kendrick lookout tower. Hand ignitions are planned around private property in the coming days once fire has reached a predetermined location in efforts to protect property and values at risk.

Fire will continue to work its way through timber stands consuming dead and down fuels along the forest floor minimizing impacts to tree canopies. Increased smoke production may occur over the next few days and poor ventilation predicted in the forecast may result in lingering smoke around the communities of Flagstaff, Kendrick Park, Whitehorse Hills, Timberline, Bellemont, Baderville, Cameron, and Tuba City. Firefighter and public safety and ecosystem health remain the top priority for fire managers while keeping the fire within the planning area.

An amateur radio operator reported that at the Flagstaff meeting last night, the Forest Service officials said they will investigate the possibility of smaller burns to reduce smoke.

The Kaibab Forest officials would like to remind people NOT to fly drones in the area of fires. Pilots only know if there is a drone in the area if they spot it. If they don’t, an impact can damage a helicopter. If the pilot spots a drone, the only thing they can do is land and wait. Please use drones responsibly.

Firefighters fight fire in Williams with helo

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Corrected 6/16/17 9:21 a.m.

WILLIAMS – With Stage 1 Fire Restrictions in effect as of 8 a.m. this morning, an amateur radio operator informed us of a fire began about 2 p.m. this afternoon in the area of the Williams Hiking Trail on the west side of Williams. The cause of the fire has not been released. All of this as a plume of smoke rose in the sky in the east from the Boundary Fire on Mt. Kendrick.

The area of fire appeared to be about an acre. A Chinook CH-47 helicopter with a Bambi Bucket was brought in and began dumping water from Santa Fe dam on the fire about 3 p.m. Firefighting efforts began to subside about 5:30

Stage I fire restrictions, will began today 8 a.m. across the entire Kaibab and Coconino national forests. The goal of the fire restrictions is to protect public health by reducing the number of preventable human-caused wildfires.
Under the restrictions, fires, campfires, charcoal, coal and wood stoves are prohibited, except within a developed recreation site. Smoking is also prohibited, except within an enclosed vehicle, building or a developed recreation site. Using a device that is solely fueled by liquid petroleum or LPG fuels that can be turned on and off is allowed in areas that are barren or cleared of all overhead and surrounding flammable materials within three-feet of the device. Fireworks are always prohibited on all national forest lands. The national forests use fire restrictions to help prevent unwanted, human-caused fires and to limit the exposure of visitors during periods of potentially dangerous fire conditions.

Implementation of fire restrictions normally occurs based on a combination of factors that are carefully measured. Criteria used to determine when to implement restrictions include things such as current and predicted weather, fuel moisture, fire activity levels and available firefighting resources. Additional restrictions may be applied as conditions warrant. An explanation of the different stages of fire restrictions and what is typically prohibited during those stages can be found online at tinyurl.com/firestagesexplained.

Fire restrictions typically remain in effect until the forests receive significant precipitation, at which time they will be rescinded.

Forest officials would also like to remind visitors that having a campfire on the national forest while under fire restrictions is a violation that carries a mandatory appearance in federal court. Visitors should use extra caution when recreating on all public lands during fire season.

Know Before You Go!
The public can obtain additional fire information via the following:
Arizona Fire Restrictions – www.firerestrictions.us/az/Arizona Interagency Wildfire Prevention and Information Website – www.wildlandfire.az.gov/
Fire Restrictions on Public Lands in Arizona and New Mexico-1-877-864-6985
Coconino National Forest – www.coconinonationalforest.us
Kaibab National Forest – www.fs.usda.gov/kaibab

Aerial Ignition Operations Begin on Kendrick Mountain

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WILLIAMS — Helicopter aerial ignition operations continue today near the Kendrick Mountain peak. The operations, in which incendiary devices are dropped from a helicopter to reduce dead and down fuels, began near the peak on Tuesday. The plan is to continue to use aerial ignition to bring fire slowly down the mountain. The tactics benefit the ecological conditions in the Kendrick Mountain Wilderness while minimizing impacts.

A community meeting in east Flagstaff (see above) on Thursday will provide information on the Boundary Fire and on potential impacts from smoke that may affect the eastern side of Flagstaff over the next several days. Health and emergency management personnel will also be on hand. Representatives of the Coconino and Kaibab national forests will discuss fire restrictions that take effect Thursday.

The meeting will be held at 6 p.m. Thursday, at the Summit Fire District, 6050 E. Firehouse Lane, Flagstaff.

For more information, details, visit inciweb.nwcg.gov/incident/5209/. Quick updates are available via Twitter at @KaibabNF and @CoconinoNF. Follow us if you would like to be updated as information is received.

Red Flag Warning in effect today

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WILLIAMS – The National Weather Service has issued a Red Flag Warning for today until 7 p.m. that covers the Williams and Tusayan ranger districts of the Kaibab National Forest due to strong winds and low relative humidity.

Visitors to the Williams and Tusayan ranger districts of the Kaibab National Forest are advised to refrain from having a campfire when Red Flag Warning conditions exist. This advisory covers all campfires across the affected area, including in developed campgrounds, for the hours during which the Red Flag Warning has been issued.

A Red Flag Warning means that critical fire weather conditions are either occurring or are imminent. A combination of strong winds and low relative humidities can contribute to extreme fire behavior. The campfire advisory remains in effect until the Red Flag Warning ends.

While the North Kaibab Ranger District is not under a Red Flag Warning, a Wind Advisory has been issued for that area today.

The Kaibab National Forest is committed to educating visitors about their role in helping prevent unwanted, human-caused fires. Avoiding having campfires on windy days is one way they can do that.

For detailed weather information including warnings issued by the National Weather Service, visit www.wrh.noaa.gov/fgz/. For homeowners interested in reducing wildfire risks at their residences, visit www.firewise.org.

Prescribed Fire Alert: Fire managers plan burn north of Jacob Lake

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FREDONIA – North Zone fire managers plan to conduct a prescribed burn within the North Kaibab Ranger District of the Kaibab National Forest as early as Thursday, June 1, if weather, fuel moistures, air quality and smoke dispersion remain favorable for meeting both forest health and public safety goals and objectives.

Hand and aerial ignitions on the 3,764-acre unit, approximately 2 miles north of Jacob Lake, could continue for several days depending on forecasted weather, fuel conditions and resource availability. By further reducing accumulated forest fuels that exist in the area, fire managers plan to reduce surface fuel loads within the unit to approximately 5 tons per acre. Currently, fuel loading through much of the Basin Unit can be characterized as moderate with an average of 10-to-15 tons-per-acre across the entire unit, according to North Zone fuels specialist Dave Robinson.

In the interest of both firefighter and public safety, forest visitors are reminded to obey all traffic signs and use caution when traveling in the vicinity of the prescribed fire as firefighters and fire-related traffic will be present, and while winds are expected to disperse the smoke to the north-northeast, motorists are cautioned to anticipate light smoke along Highway 89A throughout the day and settle into lower elevations and drainages overnight through midmorning. However, fire managers will strive to minimize smoke impacts to the community as much as possible, and will only commence ignitions when conditions exist that will allow for adequate ventilation.

As a reminder, implementation of prescribed fires is dependent on weather and fuel conditions including winds, temperature, humidity, moisture of the vegetation and ventilation conditions for dispersal of smoke, as well as prior coordination with the Arizona Department of Environmental Quality. For additional information on the Smoke Management Division of the ADEQ and to view prescribed burns authorized on any given day, please visit www.azdeq.gov/programs/air-quality-programs/smoke-management.

Additional fire information for the Kaibab National Forest can be obtained through the following sources:

· Fire Information Recorded Hotline: 928-635-8311
· Find us on Facebook: @KaibabNF
· Twitter: www.twitter.com/KaibabNF
· (Text ‘follow kaibabnf’ to 40404 to receive text messages.)
· Kaibab website “News & Events”: www.fs.usda.gov/kaibab
· InciWeb: https://inciweb.nwcg.gov/incident/5194/

Prescribed burns planned to begin this week near Tusayan

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TUSAYAN – Crews plan to begin working on two prescribed burns near Tusayan beginning Tuesday and will likely continue burning for several days providing weather conditions remain favorable for meeting forest health objectives and smoke dispersion.

Ignitions will occur tomorrow on 250 acres of slash piles on the Flying J prescribed fire project located just west of Grand Canyon airport. On Wednesday operations will shift to the Reed prescribed fire project where fire officials hope to treat approximately 600 acres using a broadcast burn. This unit is located about 6 miles east of Tusayan.

The removal of cured slash piles is critical for reducing hazardous fuels that can often threaten rural communities, particularly when they are located adjacent to developed infrastructure and residential homes. Broadcast burning is utilized to introduce fire to ground surfaces over much wider areas which also consume accumulations of dead and down debris lessening the potential for a catastrophic wildfire.

Smoke is expected to disperse away from sensitive areas for both of these burns during the day. Residual smoke may settle into drainage and low lying areas overnight but will dissipate rapidly throughout the morning hours. Smoke may be visible from Highway 64 and from the communities of Grand Canyon, Valle and Tusayan. Light smoke may linger overnight and in the early 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.

Notifications of upcoming prescribed burns are provided regularly throughout the season. The public can find this information online or through a recorded hotline. Contact your local Kaibab National Forest office for additional information.

• 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

Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters

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Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter.

This recall does not affect patients who have successfully undergone cardiac procedures using these devices. Abbott has already implemented corrective actions to ensure the products perform as intended.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death. The FDA has classified this as a Class I recall, where exposure to a device presents a reasonable likelihood of serious adverse health consequences or death. The cumulative frequency of reported events in difficulty of removing the sheath, and inflation and deflation of the balloon, is 0.12 percent worldwide.

Abbott began contacting customers in March who received coronary catheters from the affected lots, and is arranging the return and replacement of all remaining products. The total number of distributed units from identified lots potentially affected is 449,661. Global Health Authorities have been notified of the voluntary recall.

Specific lots of affected product were manufactured between January 1, 2015 to January 2, 2017, and were distributed between January 13, 2015 to March 14, 2017. For more information, please see Abbott’s field safety notice.

For Important Safety Information on NC Trek Catheters see PDF.