CareFusion Alaris PC Unit, Model 8015 Recalled due to Error Code that may Result in Serious Injury

Risk Manager and Critical Care Medicine personnel are informed by the FDA that CareFusion Alaris PC Unit, Model 8015 is recalled because an error code may result in serious injury, including death.

Background of CareFusion Alaris PC Unit, Model 8015

Alaris PC Unit, Model 8015, by CareFusion 303 Inc, is part of the Alaris electronic infusion pump. The electronic infusion pump is used for the delivery of medications to patients through various acceptable routes of administration (i.e. intravenous, epidural, etc.) The CareFusion Alaris PC Unit, Model 8015 with PC unit power supply board P/N TC10005122 was manufactured after January 2011.

FDA Alert on CareFusion Alaris PC Unit, Model 8015

FDA’s reason for the recall is that a component on the PC unit power supply board of CareFusion Alaris PC Unit, Model 8015 causes an error code which can cause either a delay in patient therapy or an inability to make programming changes to current infusions. This may lead to serious injury, including death.

The affected product’s distribution dates were from January 1, 2011, to May 31, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on CareFusion Alaris PC Unit, Model 8015

“On June 27, 2012, CareFusion sent an Urgent Medical Device Recall Notice to customers who purchased the Alaris PC unit, model 8015. CareFusion will contact customers by phone within 60 days of receiving the letter to schedule a visit to replace the affected power supply board on the PC unit.

• If the error messages are observed, remove the PC unit from use and contact the CareFusion Recall Support Center at 1-888-562-6018.
• For clinical areas administering high-risk infusions, consider having additional devices as back-up until affected devices are remediated.”

Contacting the FDA to report cases with CareFusion Alaris PC Unit, Model 8015

In case of detection of adverse events or side effects related to the use of CareFusion Alaris PC Unit, Model 8015, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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