BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER HEALTHCARE CORP

    MDR report key: 4482976 · Received August 1, 2014

    Report

    Report Number
    1314492-2014-47451
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE DOOR LATCHING ISSUES AS A DOOR NOT FULLY LATCHED ALARM. EVALUATION FOUND THE DOOR WAS ABLE TO LATCH CLOSE BUT THE FORCE REQUIRED TO SECURE DOOR WAS ABOVE EXPECTED LEVELS AND IF NOT APPLIED WOULD CAUSE UNIT TO GO INTO A DOOR NOT FULLY LATCHED ALARM. THE DOOR HOOKS AND LATCH PINS WERE REPLACED TO CORRECT THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP HAD A DOOR NOT LATCHING ISSUE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452236 BAXTER HEALTHCARE CORP HEALTHCARE CORP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1