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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
Recall Number Z-1992-2012
Classification Class I
Code Info Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers.
Product Distributed Qty 38,225 pumps
Reason For Recall Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of the IV set roller clamp, the anti free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow. When the pump and IV set are operated in accordance with the Instructions for Use (IFU), any potential for free flow is fully mitigated. From the time the set is properly inserted into the pump to the time the set is removed from the pump, the pump's free flow protection remains activated regardless of the integrity of the clip catch. Additionally, as described in the IFU, the roller clamp should always remain closed after priming the line until the set is properly inserted into the pump. A warning light is present inside the pump which only turns off once the IV set anti free flow clip is properly positioned in the clip channel in the pump. Further, per the IFU, the roller clamp is to be closed at the end of infusions before disconnecting the patient. Adherence to the IFU by the user mitigates the risk of potential free flow should the clip catch be broken. The original report of correction informed the Agency of a retrospective upgrade conducted at 14 customer accounts that consisted of a new hardware component intended to act as a door jam and a new software version G03. B. Braun is expanding this field correction to include the following additional actions: -- Customers with Infusomat Space Pumps with software versions G02 and prior are being informed of the importance of following the Instructions for Use in order to avoid potential IV set misloading and are being provided with information regarding the potential risks should the IFU not be followed. Included in the letters to these customers are necessary user actions to ensure proper IV set loading and unloading, as well as user recommendations. Proper use guides in the form of a poster and a DVD are also being provided with these letters to B. Braun customers. -- All pumps in the market, which included pumps with G03, G02 and prior software versions, are being upgraded to a metal clip catch. This new material strengthens the clip catch and eliminates potential for breakage of the current clip catch which is fabricated from plastic. During the upgrade process of pumps with G03 software where the door jam was previously installed, the door jam will be removed from the pump. The original intent of the door jam was to minimize potential for breakage, but did not eliminate possible breakage when high forces are applied.

Event Detail

Event Id 62115
Product Type Devices
Status Ongoing
Recalling Firm B. Braun Medical, Inc.
City Allentown
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
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