Safety Warnings Issued for Heartmate II Implantable Devices after Deaths

Safety warnings are being issued on Heartmate II pump devices after the deaths of four patients. The manufacturer, Thoratec Corp., reports that the deaths occurred while attempting to switch to a backup system controller, which monitors performance of the device. To do this, the pump must be disengaged. But struggles with it can cause a patient to become dizzy or lose consciousness.

Two of the deaths involved patients that struggled to exchange system controllers while alone, despite labeling that indicates this shouldn’t be done without first contacting the hospital.

Additionally, five other patients experienced some type of adverse event, either decreased blood flow because of difficulty switching controllers or becoming unconscious.

These implantable medical devices are used in patients with advanced heart failure. They assist the heart in pumping blood and are connected to an external battery pack and a system controller, which alerts patients when the battery is running low.

The manufacturer indicates that eight of the nine events involved patients who were using a newer system controller that was sold in the United States beginning in May 2013. More than 2,000 patients have been prescribed the new system controller. They warn that patients at greatest risk are those who were trained on the older controller model. The company emphasizes the necessity of being retrained on the new controller.

When a medical device causes serious or fatal harm to a patient, it could allow a product liability claim to be filed. Heart-related recalls and investigations abound, for instance, the FDA has of late been looking into the link between the diabetes drug Onglyza (or Kombiglyze XR) and heart failure.

A defective product liability claim depends on the nature of the circumstances and if it was defective. It may have been something in the design or manufacturing that went wrong. The fault could lie in improper marketing or faulty labeling.

It’s important to contact an attorney, not only to learn if there is a case, but also to determine who might be liable. Examples of parties may include the: 

  • manufacturer;
  • testing laboratory;
  • retail supplier; or
  • healthcare provider/facility. 

There is a lot more to know about a medical device defect than the fact that it malfunctioned. This is the reason that Gacovino, Lake & Associates practice product defect law: to stand up for the rights of injured parties that had no recourse. Receive monthly updates on defective products by signing up for our newsletter, Torts & More.

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