BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 3940743 · Received April 22, 2014

    Report

    Report Number
    2183502-2014-00244
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    July 25, 2013
    Report Date
    April 21, 2014
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION OF THE INTERIOR OF THE DEVICE FOUND FLUID RESIDUE AND EVIDENCE OF THERMAL DAMAGE TO THE POWER SUPPLY BOARD. TESTING WAS ABLE TO REPLICATE THE OCCURRENCE BY INTRODUCING LARGE AMOUNTS OF FLUID INTO THE DEVICE. THE FLUID MIGRATED INTO THE POWER SUPPLY CHAMBER WHERE IT ELECTRICALLY SHORTED THE AC CONNECTION THE POWER SUPPLY BOARD. THE ELECTRICAL SHORTING AT THE AC/POWER SUPPLY CONNECTION GENERATED HIGH TEMPERATURES THAT RESULTED IN THERMAL DAMAGE TO THE INTERIOR OF THE DEVICE. THE SMOKING OF THE DEVICE OBSERVED BY THE CUSTOMER WAS A RESULT OF THE ELECTRICAL SHORTING. THE INVESTIGATION OF THE DEVICE FOUND AN EXCESS OF FLASH AROUND THE BARREL CLAMP SEAL AND A SLIGHTLY LARGER ID OF THE SEAL WHICH COULD HAVE CONTRIBUTED TO THE FLUID INGRESSION TO THE DEVICE INTERIOR.

    Description of Event or Problem · 1

    ACCORDING TO USER FACILITY, THE PUMP BATTERY WAS SMOKING. NO ADVERSE EFFECTS TO USER OR PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242624 MEDFUSION 4000 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE