2014年4月3日 星期四

安全警訊 PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge


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PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge (原出處)

 
  ＊＊＊ 衛署醫器輸字第022952號 ＊＊＊ 台灣德爾鉻醫療器材有限公司
[Posted 04/02/2014]
AUDIENCE: Biomedical Engineering, Nursing, Critical Care Medicine, Risk Manager, Pediatrics
ISSUE: Dräger initiated a nationwide recall of the optional PS500 Power Supply Unit used with the Evita V500 and Babylog VN500 ventilators. The device may not indicate a low battery charge. The first indication of diminished battery capacity may occur when the battery is totally depleted. In some cases, neither the "Battery Low" nor the "Battery Depleted" alarm was triggered when the remaining battery capacity fell below 10%. However, when the battery depleted totally, the power fail alarm was generated.
Should the battery become totally depleted, mechanical ventilation will stop. Manual ventilation will be required until the device is connected to main power.
BACKGROUND: Initial investigation revealed that the battery capacity was reduced due to the occurrence of sulfation within the battery. Frequent short-time use of PS500 battery power can increase sulfation, further reducing the battery capacity. When sufficient sulfation occurs, the connection to main power cannot guarantee fully charged batteries and the charge indicator may not reflect the currently available battery capacity.
This recall only affects Evita V500 and Babylog VN500 ventilators equipped with the optional PS500 power supply unit. Affected devices were distributed nationally between June 2011 and January 2014.
RECOMMENDATION: As an interim solution, the batteries in the PS500 will be replaced free of charge. Until the batteries are exchanged, Dräger recommends that the user:
1. Use an affected device for patient transport only if absolutely necessary.
2. Not rely on the battery charge status indicator.
3. Always supervise the patient and the ventilator during transport. Ensure that a manual resuscitator is available for manual ventilation, as recommended in the instructions for use.
4. If the power failure alarm occurs during transport, immediately provide manual ventilation and connect the ventilator to a wall power source to resume ventilation.
After the above mentioned battery exchange, Dräger recommends the following:
1. Minimize battery usage.
2. Avoid brief usage and charging of the PS500 (1 – 20 minutes).
3. Avoid patient transport lasting longer than 1 hour.
4. Make sure to charge the batteries for at least 24 hours.
The exchange of the existing batteries and the above recommendations are only a temporary solution to ensure a minimum operating time of 1 hour independent from main AC power. The permanent solution, once available, will also be provided free of charge.
A recall notification has been sent to all current users of the recalled Evita 500 and Babylog VN500 ventilators and is available on the Dräger website at www.draeger.com. Users are being contacted by a Dräger Service representative to schedule the replacement of the PS500 batteries free of charge.
For questions regarding the operation and/or servicing of affected Dräger ventilators in the United States, call Dräger Service Technical Support at 1-800-543-5047 (press 4 at the prompt) between the hours of 8AM to 8PM EDT Monday through Friday, or contact Dräger by email at info.usa@draeger.com.

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.htm
  • 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
[04/02/2014 -Firm Press Release - Dräger]
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2014年4月2日 星期三

一級召修 Thoratec Corporation, HeartMate II LVAS Pocket System Controller


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Recall Class: Class I
Date Recall Initiated: March 4, 2014
Catalog Numbers:106015 and 106016 – HeartMate II LVAS Implant Kit with Pocket Controller
106762 and 106017 – HeartMate II LVAS Pocket System Controller
107801 – HeartMate II LVAD Pump and Pocket Controller Kit
105109 – Pocket System Controller removed from packaging
Distribution Dates: August 2012 – June 2014
Use: The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. The controller is powered by batteries or connected to a main power supply.
A back-up system controller is provided for use in case of a device alarm or malfunction. Instructions and training are provided on how to switch from one system to the other.
Recalling Firm:Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588-3270
Reason for Recall:Thoratec has received five reports of serious injury and four reports of death associated with difficulty in changing from the primary system controller to a back-up system controller. All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller. The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function.
The use of this product may cause serious adverse health consequences, including death.
Public Contact:Individuals with questions regarding this recall may contact Thoratec Corporation at 800-528-2577 or 925-847-8600, 7 days per week, 8:00 AM – 5:00 PM, Pacific Time.
FDA District: San Francisco District Office
More Information about this Recall: On March 4, 2014, Thoratec Corporation sent an "Urgent Medical Device Correction" letter by email to all affected customers. Customers were requested to complete and sign an Acknowledgement Letter that was attached to the email and return it to Thoratec via FAX or scanned email copy.
The letter identified the product, problem and the actions to be taken:
  • Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller.
  • All patients using the Pocket System Controller and their caregivers should be retrained on the use of the device and be provided with updated Patient Handbook information.
  • Thoratec plans to update labeling and training materials for the device to provide better instruction on connecting the driveline to the Pocket System Controller.
About Class I RecallsClass I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
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