The U.S. Food and Drug Administration (FDA) announced it was issuing a Class I recall for Smiths Medical Medfusion Model 4000 Syringe Infusion Pump.Because of defects, the device can go into alarm mode, shutting it off. In some cases, this can result in serious injury or death, according to the recall.
Why this Medical Device was Recall?
When the pump stops, it can cause a delay or interruption of therapy to the patient. Patients receiving critical therapy, such as vasopressors, could be seriously injured or die from the shut off. Vasopressors are drugs that stimulate the contraction of some blood vessels.
Infusion Pumps and FDA Class I Recall?
The pumps involved were sent out from Sept.10, 2010, to Feb. 3, 2012. The firm said it has not received reports of serious patient injury or death.The Medfusion 4000 is a wireless electronic infusion pump for providing intravenous (IV) infusions of fluids, medications, blood and blood products to adults, children and newborns.The problem with the pump was discovered by a Smiths Medical representative who let the company know that the pumps needed to have their software upgraded. The upgrades were completed February 15, 2012, for the company ‘s U.S. clients. Canadian pumps are still being upgraded.Class I recalls are the most serious type of recall the FDA can issue. They are given when there is a reasonable probability that using the product could lead to serious health consequences or death.The FDA posted the recall to its website Aug. 2, 2012, although the recall began in early February.
Source: FDA
Contact a Defective Product Lawyer in San Diego Today
If you or someone you love has suffered harm from a defective medical device or product, you may be eligible for financial compensation. To learn more, contact a personal injury lawyer at The Law Office of Melinda J. Helbock today.