FDA Recalls Defective Medical Device Because of Problems

by | May 29th, 2014

Companies who market medical devices and equipment have a responsibility to ensure the safety of their products; however, testing doesn’t always catch every problem and sometimes devices are released that can cause patients serious harm. When this occurs, not only may the company face civil litigation filed by those who were harmed but also costly recalls of the defective medical device.

The U.S. Food and Drug Administration (FDA) recently announced such a recall in regards to problems that were discovered with the Baxter ABACUS TPN Calculation software. An FDA press release stated the problems could result in a patient fatality if not corrected immediately.

The FDA goes on to explains pharmacists use the software to determine the correct amount of ingredients to include in Total Parenteral Nutrition orders for patients who are unable to eat or drink orally.  Experts say the software currently contains errors that could cause mistakes in the amounts of ingredients included in each order, which could lead to toxicity and possibly an overdose in patients.

Symptoms of such errors include:

  • Nausea
  • Vomiting
  • Dizziness
  • Fatigue
  • Pulmonary edema
  • Congestive heart failure
  • Seizures
  • Death

The manufacturer is asking users of versions of the software earlier than v3.1 to contact the company in order to receive a free upgrade that will correct the issue.

Our team of Cleveland Class Action attorneys at the law firm of Nurenberg, Paris, Heller & McCarthy know the dangers a defective medical device can pose and are happy to see the problem with the Baxter ABACUS TPN Calculation software being corrected immediately.