BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 2160443 · Received June 20, 2011

    Report

    Report Number
    9615050-2011-00443
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 7, 2011
    Report Date
    May 25, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    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 HAD UNRESTRICTED FLOW. THIS WAS DUE TO A DISCONNECTED REGULATOR CLOSER. WHEN THE DEVICE CASSETTE DOOR IS CLOSED, THE REGULATOR OPENER OPENS THE CASSETTE FLOW REGULATOR. WHEN THE DEVICE CASSETTE DOOR IS OPENED, THE REGULATOR CLOSER CLOSES THE CASSETTE FLOW REGULATOR. THIS OPENING AND CLOSING ACTION OF THE CASSETTE FLOW REGULATOR PREVENTS FREE FLOW FROM OCCURRING. IF THE REGULATOR CLOSER IS NOT SNAPPED INTO POSITION ON ITS MATING POST ON THE MECHANISM CHASSIS, THE CASSETTE FLOW REGULATOR WILL NOT BE CLOSED WHEN THE DEVICE DOOR IS OPENED. THE CAUSE OF THE DISCONNECTED REGULATOR CLOSER COULD NOT BE DETERMINED. IT MAY HAVE BEEN DUE TO IMPROPER ASSEMBLY OF THE REGULATOR CLOSER ASSEMBLY. IF THE REGULATOR CLOSER ASSEMBLY IS NOT PROPERLY INSTALLED, AFTER SOME FREQUENCY OF USAGE, THE REGULATOR CLOSER MAY BECOME DISCONNECTED. EVENT PROBLEMS CODES: THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE. 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 HAD UNRESTRICTED FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE: LIST #12097,| SN (B)(4)