BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3853312 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04443
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 30, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM, WHICH WAS REPRODUCED. SYSTEM ERROR 105 ALARMS WERE CONFIRMED AND WERE DETERMINED TO BE CAUSED BY A FAILED MOTOR ASSEMBLY FLEX. THE FAILED MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED SYSTEM ERROR 105. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55399 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1