BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 WITH DATAPO

    MDR report key: 2191427 · Received July 27, 2011

    Report

    Report Number
    9615050-2011-00578
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 28, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DELIVERED LESS THAN EXPECTED. THIS WAS DUE TO LOOSE INPUT/OUTPUT VALVE PINS. THIS RESULTED IN THE INPUT VALVE TO REMAIN CLOSED AND PREVENTED FLUIDS FROM ENTERING THE PUMPING CHAMBER OF THE CASSETTE. THE CAUSE OF THE LOOSE VALVE PINS COULD NOT BE DETERMINED. THIS MAY HAVE BEEN A RESULT OF THE PINS BEING PULLED ON WHEN THE MECHANISM FLUID SHIELD WAS REMOVED DURING CLEANING OR SERVICING OF THE DEVICE AT THE USER FACILITY. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE DELIVERED LESS THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM 1.6 WITH DATAPO 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA