BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3932093 · Received February 1, 2014

    Report

    Report Number
    1314492-2014-07281
    Event Type
    Malfunction
    Date Received
    February 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION WITH RESPECT TO THE REPORTED SYMPTOM, WHICH WAS REPRODUCED. THE MESSAGES WERE FOUND TO BE CAUSED BY LOOSE LINK SCREWS. THE LINK SCREWS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP CONSTANTLY DISPLAYED THE DOOR NOT FULLY LATCHED MESSAGE. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69106 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1