BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3862576 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04431
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 30, 2013
    Manufacturer
    BAXTER HLTHCARE 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

    MANUFACTURER REF: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM. THE DEVICE EXPERIENCED A DOOR NOT FULLY LATCHED ALARM, CORRESPONDING WITH THE REPORTED SYMPTOM. EVAL FOUND THAT THE FORCE REQUIRED TO SECURE THE DOOR WAS ABOVE EXPECTED LEVELS. THE DOOR HOOKS AND LATCH PINS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS A DOOR THAT WOULD NOT LATCH CLOSED. DURING A BAXTER EVAL, IT WAS DISCOVERED THAT THE DEVICE ALARMED DOOR NOT FULLY LATCHED. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55294 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HLTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1