BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4423229 · Received May 19, 2014

    Report

    Report Number
    1314492-2014-31573
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MORSE, SR MGR, QUALITY
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. A SYSTEM ERROR 105 WAS EXPERIENCED DURING BAXTER'S FUNCTIONAL TESTING OF THE DEVICE, AND WAS DETERMINED TO BE CAUSED BY A FAILED MOTOR AND SEVERED MOTOR MOUNT SCREWS. THE FAILED MOTOR ASSEMBLY, INCLUDING THE SCREWS, WAS REPLACED.

    Description of Event or Problem · 1

    DURING BAXTER'S FUNCTIONAL TESTING OF A SPECTRUM PUMP, THE DEVICE ALARMED SYSTEM ERROR 105. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298170 SPECTRUM INFUSION PUMP INFUSION PUMP FRN MORSE, SR MGR, QUALITY 35700

    Patients

    Seq Age Sex Outcome Treatment
    1