Attn: Thoracic Transplant Programs
Please review the following alert released by the Food and Drug Administration.
AUDIENCE: Cardiology, Surgery
ISSUE: A defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.
BACKGROUND: The intra-aortic balloon pump is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart during cardiac surgery. See the recall notice for the affected lot/serial numbers of the devices are subject to this recall.
RECOMMENDATION: Maquet Datascope Corporation notified customers by letter on March 17, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were advised that their Service Representative would arrange to replace the power supply on affected devices which would contain a new fan assembly.
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
Read the MedWatch safety alert, including a link to the Class I recall Notice, at: MedWatch safety alert