The Food and Drug Administration reports that Maquet/Datascope is recalling all IABPs due to reports of the IABP batteries failing to hold a charge, stopping unexpectedly, and having a shortened run-time which may cause the device to stop working when being operated by battery only.
This recall is being conducted to ensure that all IABP users and servicers follow each device's Operating Instructions Manual for recommendations on usage, charging, maintenance and storage of the batteries, as battery run times and discharge cycles vary between IABP models. If battery maintenance is not performed per the Operating Instructions Manual for each IABP, the battery may not provide the expected minimum run time of operating power.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Maquet/Datascope is aware of five patient deaths since March 2016, although the firm has not concluded that the deaths are due solely to the device shutting down while operating on battery power.
Maquet/Datascope Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
FDA says Maquet/Datascope will contact each customer to schedule a training visit to review a recently developed battery operations, care and maintenance reference guide specific to each IABP based on the Operating Instructions Manual(s) provided with each device.
On June 17, 2019, Maquet/Datascope sent affected customers an "Urgent Medical Device Correction" notice informing them of the potential risk of battery failure and listing actions that should be taken to minimize patient harm. The notice instructed customers to:
· Ensure the IABP is plugged into an AC power outlet when the system is not in use and whenever possible during patient use.
· Refer to the IABP Operating Instructions Manual for recommendations on portable/battery operation when transporting patients within or between facilities.
Please note, for Cardiosave Rescue and Cardiosave Hybrid IABPs only:
· Have additional charged batteries on hand during transport.
· Ensure the batteries are properly seated in the battery compartment/charger and the IABP Console is completely seated/secured into the IABP Cart.
· For Cardiosave Hybrid, you can verify if the Console is completely seated in the IABP cart by the indicator on the display.
· Check battery run time and replace batteries as required, as recommended in each IABP's Operating Instructions Manual.
Batteries should be replaced:
· After reaching the maximum number of charge-discharge cycles.
· When the battery provides less than the minimum specified run time.
· If the battery is broken, cracked, leaking or damaged.
· When the labeled lifetime of the battery is reached.
NOTE: Batteries for the Cardiosave Hybrid and Cardiosave Rescue IABPs sold before June 2015 should be replaced immediately as the labeled lifetime for these batteries is 4 years. Replacement batteries can be ordered through your sales or service representative. To determine the date of manufacture for all Cardiosave batteries, refer to the document, "Cardiosave Lithium-ion Battery Pack" ML-0795 in the "Urgent Medical Device" notice.
NOTE: CS100/CS300: Informational messages on the display screen provide information to the operator regarding the batteries. The Battery Maintenance Required message indicates that the IABP internal battery requires maintenance. The Battery test due date or Battery Replacement Date predate the current system date at startup or the internal battery has a total accumulated discharge time in excess of 100 total discharge cycles.
Ensure only Datascope approved or sourced batteries are installed and used for all replacement batteries.
Maquet/Datascope is currently developing a Cardiosave battery maintenance software upgrade targeted for early 2020. This updated software requires FDA clearance and once completed, a Maquet/Datascope service representative will contact customers to schedule the installation of the updated software at no cost.