BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4850543 · Received June 15, 2015

    Report

    Report Number
    1314492-2015-06799
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE AND FOUND IT WAS OUT OF SPEC IN RELATION TO THE REPORTED SYMPTOM, UNDETECTED AIR IN LINE, WHICH WAS REPRODUCED AND CONFIRMED DURING EVAL. IT WAS FOUND THAT THE DOOR HOOK SHIMS WERE REMOVED FROM UNDER THE DOOR HOOKS OUTSIDE OF THE FACILITY AND THE UPSTREAM SENSOR HAD BEEN RE-CALIBRATED WHICH CAUSED THE UNDETECTED AIR IN LINE. THE DOOR HOOK SHIMS WERE INSTALLED AND THE DEVICE WAS RE-CALIBRATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS UNABLE TO DETECT AIR IN LINE AT 10, 40, 100, 400, AND 800 ML/HR DURING EVAL. IT WAS ALSO REPORTED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388492 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1