Recall Underway for Certain IABPs Due to Potential Electrical Test Failure
The action, termed a “field correction” since affected units will be repaired on-site, follows at least one patient death.
Datascope/Maquet have initiated a worldwide recall of certain intra-aortic balloon pump (IABP) systems to address potential electrical test failures.
The action involves CS100, CS100i, and CS300 IABPs that were sold by Datascope, which has since merged with Maquet, a part of Getinge Group. The action, announced late last week, is termed a “field correction,” because a service representative from Datascope will be scheduling on-site visits to make repairs to affected devices.
Datascope said that it received a complaint detailing a patient death due to failure of a CS300 IABP to initiate therapy. The device displayed electrical test failure code 58 (power up vent tests fail), maintenance code 3, and an autofill failure.
The correction—affecting about 12,000 units sold around the world—also applies to any System 98 or System 98XT IABPs that were converted to a CS100i or CS300 IABP.
“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,” a press release posted on the US Food and Drug Administration site noted.
When affected devices are used, patients should not be left alone, the balloon should not be left inactive in the patient for more than 30 minutes because of the risk of thrombus formation, and the IABP should be powered on before the catheter is inserted to allow the device to complete its self-test, according to the companies. If the self-test fails and the device shows electrical test failure code 58, the IABP should be removed from service and the local Maquet/Getinge sales and service off should be contacted.
The field correction applies to IABPs distributed in the United States and more than 100 other countries between March 23, 2003, and December 11, 2013. Devices distributed after that are not affected.
Datascope Corp/Maquet. Datascope Corp/Maquet issues worldwide voluntary recall of the system CS100, CS100i, and CS300 intra-aortic balloon pumps for potential electrical test failure code. Published on: June 16, 2017. Accessed on: June 19, 2017.