BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3880254 · Received January 30, 2014

    Report

    Report Number
    1314492-2014-05110
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS RECEIVED AN EVALUATED BY BAXTER. THE REPORTED HEAT DAMAGE WAS CONFIRMED IN EVALUATION, AND CONTRIBUTED TO AN OVERHEATED WIRELESS MODULE. AS A RESULT, THE REAR CASE WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SPECTRUM PUMP EXPERIENCED HEAT DAMAGE. IT WAS ALSO REPORTED THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66439 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1