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Terminated

B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U.

FDA Recall Z-1015-2012 · Posted 2012-02-29

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2011-07-12
Date Terminated2014-11-03
Product Quantity5769

Reason for Recall

If the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed, the clip catch on the inside of the pump door may break. If the clip catch is broken and the door opened, free flow protection is ensured. If IV set is then removed from pump without closing the roller clamp, the clip may not re-engage the tubing, leaving an open fluid path with free flow pote

Firm Action

B Braun sent a letter on August 16, 2011, to their customers, that detailed the proposed G03 implementation in response to reported customer complaints. The software upgrade with the door jam was agreed upon and the eight hospitals were upgraded in November 2011.

Root Cause

Device Design

Distribution Pattern

Product was distributed to hospitals in CA and MO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMB.Braun Medical, Inc. · 2009-07-01K062700INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMB.Braun Medical, Inc. · 2006-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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