BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4810532 · Received May 29, 2015

    Report

    Report Number
    1314492-2015-06396
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 6, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPEC IN RELATION TO THE SYSTEM ERROR 105, WHICH WAS NOT REPRODUCED. SYSTEM ERROR 105 WAS CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND CAUSED BY A SEIZED MOTOR. THE FAILED MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 105. IT WAS ALSO REPORTED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349539 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1