BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3760065 · Received December 18, 2013

    Report

    Report Number
    1314492-2013-22308
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 21, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 REPORTED SYMPTOM. THE UNIT WAS RECEIVED INOPERABLE DUE TO A DOOR NOT FULLY LATCHED ALARM, WHICH CORRESPONDS WITH THE REPORTED SYMPTOM. THE EVALUATION FOUND THAT THE DOOR WAS ABLE TO LATCH CLOSED WITH A LOADED IV SET, HOWEVER, THE FORCE REQUIRED TO SECURE THE DOOR WAS ABOVE EXPECTED LEVELS. THE DOOR HOOKS AND LATCH PINS WILL BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS A DOOR THAT WILL NOT CLOSE. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661768 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1