BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780508 · Received January 7, 2014

    Report

    Report Number
    1314492-2014-01114
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    October 1, 2013
    Report Date
    December 10, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DISCOVERED SYMPTOM, WHICH WAS REPRODUCED. DOOR NOT FULLY LATCHED ALARMS WERE CONFIRMED AND WERE DETERMINED TO BE CAUSED BY FAILED DOOR LATCH HOOKS. THE FAILED DOOR LATCH HOOKS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS DISCOVERED DURING BAXTER'S TESTING THAT A SPECTRUM PUMP ALARMED DOOR NOT FULLY LATCHED. THERE WAS NO PT INVOLVEMENT BECAUSE THIS ALARM WAS EXPERIENCED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11555 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1