The US Food and Drug Administration (FDA) is working with Getinge to better understand the Maquet/Datascope intra-aortic balloon pump (IABP) malfunctions after several reports of the device shutting down while running on battery power, according to a letter to healthcare professionals issued by William Maisel, MD, MPH, chief medical officer, Center for Devices and Radiological Health at the FDA.
Devices mentioned in the letter include the Cardiosave (Hybrid and Rescue) CS300 and CS1000/CS100i.
Since 2017, complications with the device have been reported to the FDA and describe device shut down immediately after it’s disconnection from AC power, and the absence of an alarm warning before the device turning off. In addition to those complications, reports include life-threatening patient injuries such as a sudden drop in blood pressure, pump stopping, the need for resuscitation, and the loss of hemodynamic support.
Further, there are reports of the device not charging the battery, incorrect indication of battery percentage, and a prematurely depleting battery.
The root cause of the powering down of the devices is currently unknown. However, the FDA encouraged devices users to refer to the Operating Instructions Manual while the investigation is underway.
- Charging the IABP system whenever possible during patient use, and when the system is not in use in order to prevent the battery from depleting.
- Ensuring that the battery is completely charged before transporting patients within or between facilities, as well as having ancillary charged batteries on hand during transport.
- Periodically check battery run time and replace batteries as required, and as instructed in the system’s instruction manual.
“We encourage you to report to the FDA events of IABP devices shutting down while running on batteries, as well as any other battery issues that occur. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.”
Maisel, W. Device failure associated with getinge’s maquet/datascope intra-aortic balloon pumps – letter to health care providers. US Food and Drug Administration. Published November 1, 2018. Accessed November 5, 2018.