BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4802433 · Received May 26, 2015

    Report

    Report Number
    1314492-2015-06271
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    BAXTER HEALTHCARE CORP
    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). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE SYSTEM ERROR 105, WHICH WAS OBSERVED DURING POWER UP. SYSTEM ERROR 105 WAS CONFIRMED AND CAUSED BY A FAILED MOTOR FLEX. THE FAILED MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    DURING BAXTER'S FUNCTIONALITY TESTING OF A SPECTRUM PUMP, THE DEVICE DISPLAYED SYSTEM ERROR 105. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340972 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1