Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50,
FDA device recall Z-2107-2012 · posted 2012-08-01 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 607 pumps (257 USA, 350 Canada)
- Distribution
- Worldwide Distribution -- USA, including the state of CA, and country of Canada.
- Date initiated
- 2012-02-14
- Date posted
- 2012-08-01
- Date terminated
- 2012-11-14
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) (K111386) | Smiths Medical MD, Inc. | 2011-08-29 |