B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U.
FDA device recall Z-1015-2012 · posted 2012-02-29 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 5769
- Distribution
- Product was distributed to hospitals in CA and MO.
- Date initiated
- 2011-07-12
- Date posted
- 2012-02-29
- Date terminated
- 2014-11-03
- Location
- Allentown, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K083689) | B.Braun Medical, Inc. | 2009-07-01 |
| INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K062700) | B.Braun Medical, Inc. | 2006-10-26 |