BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4470057 · Received July 8, 2014

    Report

    Report Number
    1314492-2014-42013
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE SYMPTOM OF DOOR NOT FULLY LATCHED ALARMS WAS REPRODUCED AND CONFIRMED THROUGH EVALUATION. THIS CONDITION WAS CAUSED BY LOOS MECHANICAL ASSEMBLY MOUNT SCREWS. THE LOOS SCREWS ALLOWED SEPARATION BETWEEN THE FRONT CASE AND MECHANICAL ASSEMBLY, CAUSING THE FORCE REQUIRED TO CLOSE THE DOOR TO BE ABOVE EXPECTED LEVELS AND IF NOT APPLIED WOULD CAUSE THE UNIT TO ALARM DOOR NOT FULLY LATCHED. THE MECHANICAL MOUNT SCREWS WERE REPLACED.

    Description of Event or Problem · 1

    DURING BAXTER'S EVALUATION A SPECTRUM PUMP ALARMED DOOR NOT FULLY LATCHED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398713 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1