Federal health officials have issued a new warning about additional reports of problems with recalled intra-aortic balloon pumps, which continue to result in adverse events after the devices shut down unexpectedly when running on battery power, including at least two new deaths.
The FDA issued an updated Medical Device Warning for certain Maquet intra-aortic balloon pumps on November 19, indicating that more than 60 new reports have been received involving failing batteries, since a prior warning issued in November 2018.
The issues impact Maquet/Datascope Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS100/CS100i intra-aortic balloon pump (IABPs), which may contain defective batteries.
Maquet/Datascope issued a Class I intra-aortic balloon pump recall in July 2019, impacting more than 20,000 devices. At that time, the manufacturer was aware of five patient deaths. A subsequent investigation determined that at least three of the five deaths were directly caused by the sudden stopping of the pump.
The new FDA warning indicates an additional 60 adverse medical device reports have been reported, bringing the total to 75 since 2017. Since the recall, two more fatalities have been recorded in relation to the batteries failing while in use, and not plugged in to AC power. One of the reports described a serious injury to a patient who experienced sudden drop in blood pressure and the need for resuscitation. At least six reports indicated there was no alarm warning before the device shutdown.
Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices used during patient cardiac and non-cardiac surgeries. The devices are also used to treat patients with acute coronary syndrome or complications from heart failure. The devices are used on critically-ill patients in health care facilities and during transport. An interruption in treatment can result in serious patient injury or death.
FDA officials warn healthcare professionals that patients using IABP devices for life-supporting therapy may be at an increased risk of severe injuries or death in the event the battery discontinues providing hemodynamic support.
The recall included all lot numbers of the Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP and CS100/100i IABP models manufactured by Maquet/Datascope of Wayne, New Jersey. The devices were distributed for sale across the United States to medical centers and hospitals.
The recall also included instructions for healthcare providers to ensure the IABP is plugged into an AC power outlet when the system is not is use, and whenever possible during patient use. Additional warnings instructed users to check the battery run time frequently and replace it with only Datascope-approved replacement batteries, as recommended in the Operating Instructions Manual.
The newly released warning encourages physicians to only use the recalled IABP devices when plugged directly into AC power to prevent battery depletion and adverse patient events. The FDA also recommends keeping the batteries plugged in, even when the system in not in use, to keep full charge in the event the device has to be used on battery power in an emergency.
The FDA is continuing to work with the manufacturer to identify the cause of sudden battery depletion and more information will become available as new developments are made during the investigation.
Maquet/Datascope previously announced they are working on developing a Cardiosave battery maintenance software upgrade, expected to be ready in early 2020. Once the software upgrade is cleared by the FDA, the manufacturer will begin notifying customers to schedule the installation.
Customers with additional questions or concerns regarding the impacted devices are encouraged to contact Maquet/Datascope Technical Support Department at 1-888-627-8383. All adverse events involving the recalled devices should be reported to the FDA’s MedWatch Adverse Event Reporting Program.