[Posted 06/26/2018] AUDIENCE: Cardiology, Risk Management, Surgery
ISSUE: Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.
| CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp. |
|---|
|
BACKGROUND: The CARDIOSAVE Hybrid Intra-aortic Balloon Pump intra-aortic balloon pump is a cardiac assist device used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
RECOMMENDATION: Maquet Datascope Corp instructs users to:
Never place fluids on top of the unit
Ensure that the saline container and tubing do not hang directly over the IABP
In case of accidental spillage, to wipe clean immediately and have the unit serviced to ensure no hazard exists.
In case of an interruption in therapy, the letter instructed users to:
Affected customers will be contacted by Maquet Datascope Corp. to schedule on-site service of the IABP by a Maquet Datascope Corp. Sales or Service Representative. The company anticipates having the protective top cover available by late June 2018.
Customer in the U.S. looking for more information about this recall can contact Maquet Datascope Corp.’s Technical Support Department at 1-888-627-8383 (press option 3), Monday through Friday, between 8:00 am and 6:00 pm Eastern Standard Time.
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:
[06/06/2018 - Medical Device Recall - FDA]
