The firm recommends that the risks and benefits of using an affected CS100i, CS100, or CS300 IABP be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. RECOMMENDATION: On July 17, 2017, Datascope Corp./MAQUET sent affected customers an "Urgent Product Recall Medical Device Field Correction" notice informing them of the device's risks, and listing actions that should be taken to minimize the risk of patient harm until affected IABP units can be serviced. Lot Numbers: All Lots Manufactured Jto June 16, 2017īACKGROUND: Datascope Corp./MAQUET's CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps are cardiac assist devices used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.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. ISSUE: Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured Jto Jdue to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. AUDIENCE: Risk Manager, Cardiology, Surgery
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