November 5, 2018 — The U.S. Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. The company issued a letter to providers warning them about this issue Nov. 1, 2018.IABPs are used on critically-ill patients in health care facilities, including during transport. The vendor said an interruption in treatment can result in serious patient injury or death.The Maquet/Datascope IABP is a cardiac assist device placed in the descending aorta, just distal to the left subclavian artery. The device is an electromechanical system used to inflate and deflate intra-aortic balloons, which provides temporary support to the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Getinge manufactures the following Maquet/Datascope IABP devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.Since 2017, the FDA has received more than 75 medical device reports of Maquet/Datascope IABP devices shutting down while running on battery, leading to pump stop and loss of hemodynamic support.
Five of these reports described three patient deaths, although the deaths cannot be definitively attributed to the device shutting down. Other reports describe serious patient injury such as a sudden drop in blood pressure or the need for resuscitation.
DescriptionThe Datascope CS100 is a highly customizable balloon pump system that allows caregivers to deliver the best care in a variety of situations. The unit has three modes of operation: Automatic, Semi-Automatic and Manual. This allows caregivers to use the C100 to manually operate the pump, or set up the unit to offer automatic specialized therapy.The laptop-style display and keypad easily fold up and detach, allowing clinicians to remotely monitor patients. For more information on the Datascope CS100 Cardiac Assist Balloon Pump System, available refurbished from DRE, contact a DRE Representative today.