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.
FDA Recall Z-2107-2012 · Posted 2012-08-01
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Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2012-02-14
Date Terminated2012-11-14
Product Quantity607 pumps (257 USA, 350 Canada)
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- USA, including the state of CA, and country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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