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Intra-aortic balloon pumps voluntarily recalled after patient death
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The FDA issued a safety alert announcing that Datascope Corp. issued a voluntary field correction for intra-aortic balloon pumps due to a potential electrical test failure code.
The test failure code in the intra-aortic balloon pumps (CS100, CS100i, CS300, System 98 or System 98XT converted to CS 100i or CS300) has resulted in one patient death due to failure to initiate therapy. The reported death was related to a CS300 intra-aortic balloon pump with codes for autofill failure, failure to power vent and maintenance.
According to the alert, sudden interruption in intra-aortic balloon pump function may result in hemodynamic instability for patients in critical condition.
The medical team should measure risk-benefit with the intra-aortic balloon pumps if an alternative therapy is not available, according to the safety alert. Patients should not be left alone during intra-aortic balloon pump therapy, and the balloon should not be inactive in the patient for more than 30 minutes. Clinicians should be aware of any sudden shutdown due to inactivity of the balloon. Users should ensure the intra-aortic balloon pump completes a 60-second self-test before insertion of the balloon catheter.
Datascope distributed 12,000 affected intra-aortic balloon pumps in the United States and in over 100 countries between March 23, 2003 and December 11, 2013, according to the alert. Pumps distributed after the date range have not been affected.
A representative from Datascope or the Maquet/Getinge service team will contact customers with affected devices for the replacement of solenoid driver boards.