Recall Z-1015-2012 ยท FRN Pump, Infusion
B. Braun Medical, Inc.
B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U.
| Date | Feb 29, 2012 (initiated Jul 12, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| 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. |
| Quantity | 5769 |
| Distribution | Product was distributed to hospitals in CA and MO. |
| FDA record | Open on fda.gov |