BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 3874263 · Received April 18, 2014

    Report

    Report Number
    9615050-2014-02770
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 11, 2013
    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
    CO
    Reporter Occupation
    OTHER

    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 PIN WAS BROKEN. THE DEVICE DOOR COULD NOT BE PROPERLY CLOSED DUE TO THE BROKEN DOOR ROLLER PIN. 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 PIN WAS LEAVING THE DEVICE DOOR ASSEMBLY IN THE OPEN POSITION EXPOSING THE DEVICE DOOR ROLLER PIN TO CONTACT DAMAGE. THIS REPORT IS BEING MADE AS PART OF A RETROSPECTIVE REVIEW. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER PIN WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT INDICATED DAMAGED, NO FUNCTION. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP 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
    238065 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK