BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3853263 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04197
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 27, 2013
    Manufacturer
    BAXTER HEALTH CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM, WHICH WAS REPRODUCED. DOOR NOT FULLY LATCHED. ALARMS WERE CONFIRMED AND WERE DETERMINED TO BE CAUSED BY A FAILED LINK SWITCH. THE LOWER AUXILIARY ASSEMBLY, WHICH CONTAINS THE FAILED LINK SWITCH, WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED DOOR NOT FULLY LATCHED. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55323 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTH CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1