BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 3770769 · Received February 18, 2014

    Report

    Report Number
    9615050-2014-01230
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 23, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DOOR ROLLER WAS BROKEN OFF. THE DEVICE DOOR COULD NOT BE PROPERLY CLOSED DUE TO THE BROKEN DOOR ROLLER. WHEN THE DEVICE DOOR IS NOT PROPERLY CLOSED, THE CASSETTE REGULATOR WILL BE OPENED AND THE VALVES WILL NOT BE CLOSED PROPERLY WHEN THE DEVICE DOOR IS CLOSED. THE VALVES MUST BE CLOSED BY THE DEVICE MECHANISM VALVE PINS IN ORDER TO PREVENT FLUID FROM FLOWING FREELY THROUGH THE CASSETTE. THE PROBABLE CAUSE FOR THE BROKEN DEVICE DOOR ROLLER WAS LEAVING THE DEVICE DOOR ASSEMBLY IN THE OPEN POSITION EXPOSING THE DEVICE DOOR ROLLER TO CONTACT DAMAGE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THERE WERE NO REPORTS OF ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102209 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA