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Terminated

MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.

FDA Recall Z-2121-2010 · Posted 2010-08-02

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-06-22
Date Terminated2012-04-17
Product Quantity4816

Reason for Recall

Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient in

Firm Action

Consignees were sent on 6/22/10 a Smith Medical "Urgent Medical Device Correction Notice', dated June 11, 2010. The letter was addressed to Dear Risk/ Safety Managers, Distributors, Clinical/ Biomedical Engineering, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists; and Nursing, Pharmacy,and Anesthesia Professionals. The letter described the problem and product involved. It provided Advise on Action to be Taken by the User which included to 1) Determine the software version of their Medfusion pump 2. Complete and return the Confirmation Form 3. Return the completed Software Update Test Form 4. If unable or unwilling to perform the software upgrade they provided information for returning the pumps to Smiths Medical for the upgrade. For further information please contact Smiths Medical at 651-628-7280.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: AL, AK, AZ, AR, CA,CO, CT, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI. and countries of CANADA, MEXICO, NEW ZEALAND, BRASIL, HONG KONG, and GREAT BRITAIN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040899MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPMedex, Inc. · 2004-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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