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.
Recalled Product
- Maquet/Datascope Intra-Aortic Balloon Pumps (IABP)
- Models
- Cardiosave Hybrid IABP
- Cardiosave Rescue IABP
- CS300 IABP
- CS100/100i IABP
- Lot Numbers: All
- Manufacturing Dates: All
- Distribution Dates: All
- Devices Recalled in the U.S.: 22,853
- Date Initiated by Firm: May 16, 2019
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Device Use
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.
Image of a Maquet/Datascope CS300 Intra-Aortic Balloon Pump
Reason for Recall
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.
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If a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including 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.
Who May be Affected
- Health care providers and facilities using a Maquet/Datascope Intra-Aortic Balloon Pump (Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP, CS100/100i IABP)
- Patients receiving circulatory support with a Maquet/Datascope Intra-Aortic Balloon Pump
What to Do
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.
No product return is required.
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:
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- 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 Correction' 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.
- Batteries should be replaced:
- Ensure only Datascope approved or sourced batteries are installed and used for all replacement batteries.
- Complete and return page 4 of the Urgent Medical Device Correction Form by fax to 1-866-340-5660, or email at: IABPBattery2019@getinge.com.
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.
A similar software upgrade was released for the CS300 IABP and CS100 IABP in 2017. If you are unsure whether your IABP has been updated with the released software upgrade, please contact Maquet/Datascope Technical Support Department with the Model and Serial number of the IABP.
Contact Information
Customers with questions about this device correction may contact Maquet/Datascope Technical Support Department at 1-888-627-8383 (select option '3') from 8:00 AM - 6:00 PM (Eastern Time), Monday through Friday.
Additional Resources
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How do I report a problem?
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Health care providers, facilities, servicers, and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care providers employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Subprocess post installation script cydia installer.
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