BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4905686 · Received July 7, 2015

    Report

    Report Number
    1314492-2015-07321
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 13, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE SYSTEM ERROR 105, WHICH WAS REPRODUCED DURING POWER UP. SYSTEM ERROR 105 WAS CONFIRMED AND CAUSED BY A FAILED MOTOR FLEX. THE FAILED MOTOR ASSEMBLY WAS REPLACED. SEE SCANNED PAGE.

    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
    440607 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1