SILVER SPRING, MD —The US Food and Drug Administration has expanded the June 2017 onsite field correction issued for Datascope/Maquet intra-aortic balloon pumps (IABPs) to a class I recall, the agency has announced[1].
The action applies the company’s CS100i, CS100, and CS300 IABP series in lots manufactured since July 2003 and sold in the US, which the agency pegs at 5049 units. That’s a broader period than was covered by the previous field correction notice, which did not apply to IABP devices sold after December 11, 2013.
The cited problem with the devices is a “false blood-detection alarm and ingress of fluid” into the IAB, the FDA says. “If a patient requires circulatory support with an IABP and the device does not work or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.”
The agency provided technical instructions for providers with the affected devices pending on-site service by the manufacturer to correct the problem.
Recalls and field corrections have beset Datascope/Maquet IABP systems before, including in June 2011 involving malfunctioning fans potentially causing the systems to overheat and shut down unexpectedly.
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