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.
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- June 22, 2010
- Posted
- August 2, 2010
- Terminated
- April 17, 2012
- Recall Number
- Z-2121-2010
- Quantity
- 4816
- Firm Location
- Saint Paul, MN
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
Distribution
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.
Lot / Code Info
All Medfusion¿ Syringe Infusion Pumps, Models 3010 and 3010a, with Software Versions 2.0.2, 2.0.3. or 2.0.4
Root Cause
Software design
Action Taken
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.