Home Correction letter Getinge IABP Maquet / Datascope Devices: Device Failure Update – Letter to Healthcare Providers

Getinge IABP Maquet / Datascope Devices: Device Failure Update – Letter to Healthcare Providers

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22 December 2021

The United States Food and Drug Administration (FDA) provides updated information on our ongoing evaluation and monitoring of device failures associated with Getinge’s Maquet / Datascope intra-aortic balloon pump (IABP) devices, including the Cardiosave (hybrid and rescue), CS300 and CS100 / CS100i.

The FDA recently became aware that the Maquet / Datascope Cardiosave Hybrid and Rescue IABP devices may not recognize AC / wall power when devices are plugged in, which can cause devices to shut down unexpectedly.

The FDA previously released reports in November 2018 and November 2019 of Maquet / Datascope IABP devices shutting down while running on battery power, causing the pump to shut down and loss of hemodynamic support. In 2019, the manufacturer initiated a voluntary recall to take training tours and review battery quick reference guides with users.

Since September 2021, the manufacturer has announced three voluntary recalls related to the risk of device failure with the Cardiosave Hybrid and Rescue IABP devices.

  • Cardiosave IABP devices can shut down unexpectedly under very specific conditions: when the device is operating on mains, only one battery is installed in the IABP and the battery is physically removed while the battery is charging. The manufacturer is developing a software fix to resolve this issue. To see the FDA Recall Database for more information.
  • Some Cardiosave Li-Ion battery packs may have unexpectedly short run times and should not be used. See the FDA Class I Recall Notice for more information.
  • Liquid entering the Cardiosave IABP device may cause the pump to stop unexpectedly or the inability to start therapy. The manufacturer will install an Infiltration Prevention Upgrade Kit to resolve this issue for Cardiosave IABP devices and will also provide a redesigned display and emergency covers for Cardiosave Rescue IABP devices. See the FDA Class I Recall Notice for more information.

The FDA wants to ensure that healthcare providers and users of the Maquet / Datascope Cardiosave IABP devices are aware of the potential for unexpected shutdown events and manufacturer notices regarding recent recalls. These devices are used to treat critically ill patients in healthcare facilities, including transport. Interruption of treatment may result in serious injury or death of the patient.

While the FDA remains concerned about device shutdown events associated with Maquet / Datascope IABP devices, the FDA recognizes that these systems may be the best option for circulatory support for some patients.

Recommendations

The FDA recommends that users of Maquet / Datascope Cardiosave IABP devices and healthcare providers:

  • Note that device failures (when operating on battery or mains) continue to be observed in patients treated with Maquet / Datascope Cardiosave IABP devices.
  • Strongly consider having additional charged IABP devices available and ready in the event the device fails.
  • Make sure that Cardiosave IABP devices are not likely to shut down when removing a battery.
    • DO NOT eject a battery when:
      • There is only one battery in either battery charging bay and the unused battery bay is empty, and
      • The battery charges from the mains supply (indicated by a flashing LED on the battery).
    • Verify that a battery is inserted in each of the two battery bays.
  • Examine your inventory to determine if you have any of the affected Cardiosave Li-Ion battery packs.
    • Replace any affected battery with an unaffected battery and remove the affected product from areas of use.
    • Affected products are eligible for free credit or replacement.
  • Never place liquids on top of the device. In the event of an accidental spill, wipe up immediately and have the unit serviced to make sure it is safe.
  • Use the plastic weather display and rescue cover whenever the Cardiosave Rescue IABP is used outdoors, especially when there is a possibility of wet weather.
  • Report IABP device shutdown events while running on battery or AC power to the FDA, as well as any other battery issues or other device failure or patient injury resulting from the device. For details on reporting, see Reporting Problems to the FDA.
  • If possible, return devices associated with or suspected of being associated with any adverse event or device malfunction or failure to the manufacturer for evaluation to help them and the FDA better understand the issue.
  • Contact Getinge if you have any questions about the recent Cardiosave recalls, or if you haven’t received letters from the manufacturer’s customers, at 1-888-943-8872, Monday through Friday, 8:00 a.m. to 6:00 p.m. EST.

The FDA recommendations in the November 2019 letter to healthcare providers have not changed for users and maintenance departments of Maquet / Datascope IABP devices.

Fund

The lABP Maquet / Datascope is a cardiac assist device placed in the descending aorta, just downstream of the left subclavian artery. The device is an electromechanical system used to inflate and deflate intra-aortic balloons, which provides temporary support to the left ventricle of the heart by increasing coronary perfusion and reducing left ventricular work. Getinge no longer manufactures the CS300 and CS100 / CS100i IABP devices; however, these devices can still be used. Currently available Maquet / Datascope IABP devices are the Cardiosave Hybrid and the Rescue.

As of 2017, the FDA has been evaluating medical device reports regarding the discontinuation of Maquet / Datascope IABP devices. There can be multiple root causes for device failures, and the FDA continues to work with Getinge to understand the root causes and possible risk mitigation measures. In 2019, the manufacturer initiated a voluntary recall due to the potential risk of battery failure in which Getinge contacted customers to schedule a training visit to review updated battery instructions and instructions for use, care and maintenance. In addition, the manufacturer provided a quick reference guide specific to each IABP device based on the user instruction manuals.

At this time, the extent of the root causes or rate of incidence of shutting down Maquet / Datascope IABP devices while running on battery or AC power is not known. The FDA continues to assess the information provided by the manufacturer to determine factors that may contribute to device failure events, as well as possible risks and mitigation measures.

The manufacturer plans to implement software changes for the Cardiosave IABP devices that aim to resolve battery issues and device failures. Proposed software changes must be submitted to the FDA for review and clearance. The manufacturer will install various internal and external component upgrades which will be available in an entry prevention upgrade kit for Cardiosave IABP devices. The manufacturer will also provide redesigned display and rescue covers for the Cardiosave Rescue IABP devices.

FDA actions

The FDA continues to work with the manufacturer to investigate and address the root causes of failures in Maquet / Datascope Cardiosave IABP devices when running on battery or AC power and will keep the public informed if important new information or recommendations become available.

Report problems to the FDA

The FDA encourages healthcare providers to report any adverse event or suspected adverse event encountered with Getinge Maquet / Datascope IABP devices.

Prompt notification of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact details

If you have any questions about this letter, contact the Division of Industry and Consumer Education (DICE).