BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION® 3500 SYRINGE PUMP

    MDR report key: 7118410 · Received December 14, 2017

    Report

    Report Number
    3012307300-2017-02592
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Report Date
    April 2, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE TAMPER SEAL WAS BROKEN AND THE DEVICE WAS CRACKED ON THE TOP CASE, BOTH PLUNGER CASES, AND THE BATTERY DOOR AS WELL AS A DAMAGED PLUNGER CABLE. A REVIEW OF THE EVENT HISTORY LOG FOUND A MOTOR RATE ERROR. OCCLUSION TESTING CONFIRMED THE MOTOR RATE ERROR. IT WAS DETERMINED THE CAUSE OF THE ISSUE WAS RELATED TO OLD GREASE COVERED WORM COUPLING FACETS, OID COMPONENTS, AND GENERALLY WORN OUT DUE TO NORMAL WEAR. IT WAS INDICATED THAT THE PUMP WAS OVER 7 YEARS OLD. BASED ON THE EVIDENCE, THE ROOT CAUSE WAS ATTRIBUTED TO NORMAL WEAR OF THE DEVICE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A MOTOR RATE ERROR OCCURRED TO A SMITHS MEDICAL MEDFUSION® 3500 SYRINGE PUMP. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895778 MEDFUSION® 3500 SYRINGE PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 3500

    Patients

    Seq Age Sex Outcome Treatment
    1