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As Blood-Pumping Device Death Toll Reaches Five, FDA Takes Action

By Burg Simpson

November 26, 2019   Ohio Legal Updates, Ohio Products Liability

On November 19, 2019, the FDA circulated its second strenuous warning to healthcare providers with respect to Getinge’s Datascope/Maquet intra-aortic balloon pump. The balloon pumps are designed to provide blood-pumping assistance to the hearts of critically ill or injured patients. However, Getinge’s pumps are battery-powered, and with that have come a barrage of reported issues including failure to hold a charge, sudden shutdowns, and shortened battery run times. These battery issues have led to fear that the pumps could shut down when it matters most.

Indeed, the FDA has received numerous reports of injuries linked to Getinge’s balloon pumps. Back in November 2018, the FDA distributed its first letter to healthcare providers in response to these troubling reports. Since the initial letter in November 2018, the FDA has received over 60 additional device reports related to the pumps’ battery issues, including two patient deaths and one serious patient injury. The FDA is now aware of at least five patient deaths and more than 135 reports linking the device with battery issues.

What is an intra-aortic balloon pump?

 An intra-aortic balloon pump is a mechanical device that helps the heart pump blood. The device consists of a catheter and a balloon. The catheter is a long thin tube that is positioned in the patient’s aorta, the artery that takes blood from the heart to the rest of the body. On the other end of the catheter is a balloon that inflates and deflates to the beat of the patient’s heart. When working as intended, the balloon pump will reduce the strain on the patient’s heart by assisting the heart in pumping blood to the rest of the body.


When are intra-aortic balloon pumps used?

Intra-aortic balloon pumps are used in critically ill or injured patients in healthcare facilities and during transport. The pumps are commonly used during surgery and to treat patients with acute coronary syndrome or complications from heart failure.


What are the risks of intra-aortic balloon pump failure?

 If the intra-aortic balloon pump fails, the device will stop assisting in the pumping of blood and the patient may lose circulatory support. For those critically ill or injured patients requiring the pump for life-supporting therapy, the consequences can be grave. In addition to reports of patient deaths, the FDA has received accounts of patients experiencing severe drops in blood pressure and the need for resuscitation.

If you or a loved one has suffered injuries that you suspect could be attributed to an intra-aortic balloon pump, contact one of the experienced product liability attorneys at Burg Simpson’s Cincinnati office today. Our award-winning team of lawyers has the knowledge and resources to investigate your potential claim and hold dangerous device manufacturers accountable for the harm they cause. Call 1-513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.

 

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