B. Braun just issued a recall of its Infusomat Space Infusion System over the potential for breakage of an anti free flow flip catch, the U.S. Food & Drug Administration (FDA) just announced. The recall was designated a Class I by the agency, which is its most serious designation and involves a situation in which there is a reasonable probability that use of or exposure to the recalled product will cause serious adverse health consequences or death.
This recall expands a previous recall, initiated by B. Braun in January, 2012.
Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. The defective anti free flow clip catch is located inside the infusion pump door. Misloading of the anti free flow clip catch may create the potential for free flow of medication, which, especially when narrow therapeutic range drugs are involved, can cause life-threatening effects and injuries.
The recalled Infusomat Space Infusion system pumps were distributed from November 6, 2008, to December 29, 2011. The following model numbers are involved: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99, with software versions G03, G02, or older
The B. Braun Infusomat is an infusion pump system used in hospitals to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients.
As part of the expanded recall, B. Braun is contacting customers to make arrangements to have the metal clip catch added to all pumps, as well as modifying door jambs on certain models.
- All Infusomats on the market, including pumps with software versions G03, G02, or older, are being upgraded with a metal clip catch, which strengthens the clip catch and eliminates the potential for breakage of the current, plastic, clip catch.
- The doorjamb on pumps with G03 software will be removed. The original intent of the doorjamb was to minimize the potential for breakage; however, this does not eliminate breakage with high forces.
- Inclusion of pumps with software versions G02 or earlier. Note: These customers were reminded about the importance of following the instructions for use to avoid potential IV set misleading and were provided with information about the potential risks that may occur when instructions for use are not followed and the IV set is misloaded.
B. Braun Medical, Inc. is located at 901 Marcon Boulevard. Allentown, Pennsylvania, 18109-9512; B. Braun Customer Support can be reached, toll-free, at 1.800.627.7867.
Last year, we wrote that B. Braun recalled its Outlook 400ES Safety Infusion System, Model Number 621-400ES in another Class I recall, because the hardware in the defective medical device might become unresponsive.