Supply Chain Woes Wreak Havoc on Getinge IABP Production

On Nov. 29, Getinge posted a notification letter informing customers of a shortage of Maquet/Datascope intra-aortic balloon (IAB) catheters, new Cardiosave intra-aortic balloon pump (IABP) devices, and Cardiosave IABP parts. The company pointed to ongoing supply chain issues as a factor in the shortage and noted that it has significantly impacted the ability to build IAB catheters, IABP devices, and parts due to not having sufficient raw materials. In response to the letter, the FDA added IABP devices to the medical device shortage list.

The shortage has prompted the company to revise its Cardiosave safety disk and lithium-ion battery maintenance guidance. Based on current supply limitations, the maintenance schedule of the safety disk has been changed from every four years or six million cycles to every four years or nine million cycles. The extension, according to Getinge, is contingent on the safety disk continuing to pass the Pneumatic Module Leak Test. The leak test should be performed before or after each use. If blood is suspected to have entered the safety disk, the pump should be evaluated by biomed/technical service to determine if it has or not and contaminated components should be replaced if necessary.

The lithium-ion battery maintenance schedule has been updated so that battery replacement may not be necessary at 200 full discharge cycles or after four years of operation. However, this change is pertinent only when the individual battery run time is ≥ 45-minutes at a heart rate ≤ 120 beats per minute. Additionally, the temporary maintenance change should only be followed when the total battery runtime is ≥ 90-minutes. The company recommends sticking to the original maintenance schedule if the hospital in which the battery is being used requires battery time in excess of 90-minutes.

If a replacement pump is needed due to an IABP undergoing service, contacting a local sales representative may help locate a temporary IABP. Additionally, Getinge recommends keeping it informing of any underutilized IAB catheters or IABPs that could be shared with hospitals in need.

While the company is still manufacturing IABs, IABP, and spare parts, it conceded that production is at a lower volume then is needed to quickly fulfill open orders. Currently, there is no clear timeline of when production will return to normal.

“The production team is continuously improving output in addition to improving our processes to avoid future disruptions,” wrote Jennifer Paradise, vice president of Cardiac Assist at Getinge, in the notification letter. “However, due to the persistently high volatility in our global supply chain, we are not in a position to provide dates for when these items will return to normal production. We remain committed to supporting patients and clinicians and deeply regret this supply disruption.”