BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6035381 · Received October 17, 2016

    Report

    Report Number
    1314492-2016-04916
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    August 1, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYSTEM ERROR 105 WHICH WAS NOT REPRODUCED. SYSTEM ERROR 105 WAS CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND FOUND TO BE CAUSED BY A SEVERED MOTOR MOUNT SCREWS. THE FAILED MOTOR ASSEMBLY AND SCREWS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 105. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686852 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1