BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 3823159 · Received February 19, 2014

    Report

    Report Number
    9615050-2014-01317
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 22, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AT THE USER FACILITY. DURING TESTING, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. 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 FEELY 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. ADDITIONALLY DURING TESTING, THE DEVICE ALARMED WITH A 9404 (REED SWITCH DOES NOT MATCH CONTROL KNOB SIGNAL) ERROR CODE. THIS WAS DUE TO A DAMAGED DISPLAY CIRCUIT BOARD. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF CONTINUOUS ERROR 94-4. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105175 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK