BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3071133 · Received April 8, 2013

    Report

    Report Number
    1314492-2013-00365
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. THE EVALUATION FOUND THAT THE SCREW WHICH STOPS THE UPPER SWITCH BRACKET FROM MOVING WAS LOOSE, AND THAT THE GAP BETWEEN THE UPPER HOOK AND THE SWITCH WAS OUTSIDE OF SPECIFICATION. WHEN PRESSURE WAS APPLIED TO THE CLOSED DOOR, THE SWITCH BRACKET WOULD MOVE FROM ITS INTENDED POSITION AND CAUSE INTERMITTENT OPENINGS OF THE UPPER HOOK SWITCH. WHEN THIS SWITCH OPENED, THE PUMP WOULD TURN ON. THE DEVICE WAS REPAIRED BY ENSURING THE SPECIFIED GAP BETWEEN THE UPPER HOOK AND THE SWITCH, AND BY TIGHTENING THE SWITCH BRACKET SCREW USING THE SPECIFIED AMOUNT OF TORQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PUMP WAS TURNED OFF THE PUMP WOULD THEN TURN BACK ON BY ITSELF. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144292 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE 35700

    Patients

    Seq Age Sex Outcome Treatment
    1