B. Braun Infusomat Space Infusion System – Expansion of Recall from January, 2012

Recall Class: Class I

Date Recall Initiated: March 23, 2012

Product: B. Braun Infusomat Space Infusion System.

Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 with software versions G03, G02, or older

Range of Manufacturing and Distribution Dates: Affected pumps were distributed from November 6, 2008, to December 29, 2011.

Intended Use: The Infusomat is an infusion pump system used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients. This device is used in hospitals.

Recalling Firm:
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown, Pennsylvania 18109-9512

Reason for Recall: This is an expansion of a previous recall, initiated by B. Braun in January, 2012, due to the potential for breakage of the anti free flow clip catch located inside the infusion pump door. 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. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.

The company is expanding the field correction to include the following additional actions:

• All Infusomats on the market, which includes pumps with software versions G03, G02, or older, are being upgraded with a metal clip catch. This new material strengthens the clip catch and eliminates the potential for breakage of the current clip catch which is made of plastic.
• The door jamb on pumps with G03 software will be removed from the pump. The original intent of the door jamb was to minimize potential for breakage. However, it does not eliminate breakage when high forces are applied.
• Inclusion of pumps with software versions G02 or earlier. These customers were reminded about the importance of following the instructions for use to avoid potential IV set misloading. Customers were provided with information about the potential risks that may occur when instructions for use are not followed and the IV set is misloaded.

Public Contact: Customers with questions about this recall may contact B. Braun Customer Support at 1-800-627-7867.

FDA District: Philadelphia

FDA Comments:

On March 23, 2012, B. Braun sent an urgent medical device correction letter to all Infusomat Space Infusion System customers with software version G02 and older. Customers were informed that B. Braun would be contacting them to make arrangements to have the metal clip catch added to all pumps. They were also reminded about the importance of following the pump’s instructions for use to avoid potential IV set misloading. Customers were also provided with information about the potential risks that may occur if the instructions for use are not followed.

Also, on March 23, 2012, B. Braun sent a separate letter to customers with software version G03 to inform them that it will be removing the door jamb from the pumps and upgrading pumps with the metal clip catch. Customers were informed that B. Braun would be contacting them to make arrangements to upgrade the pump and remove the door jamb.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.