Recall Z-2107-2012 ยท FRN Pump, Infusion
Smiths Medical ASD, Inc.
Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
| Date | Aug 1, 2012 (initiated Feb 14, 2012) |
| Status | Terminated |
| Reason | Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation. |
| Root cause | Software design |
| Action | Consignees of Medfusion 4000 pumps with software version 1.0 & 1.1 were visited by a Smiths Medical representative on 2/14/12 informing them that their pumps require a software upgrade. A record of this software upgrade was documented as part of the records for this action. |
| Quantity | 607 pumps (257 USA, 350 Canada) |
| Distribution | Worldwide Distribution -- USA, including the state of CA, and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) Smiths Medical MD, Inc., Aug 29, 2011 |