BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 4595097 · Received March 10, 2015

    Report

    Report Number
    9615050-2015-00596
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    January 1, 2014
    Report Date
    December 30, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011442
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THAT THE DEVICE DID NOT PASS THE UNRESTRICTED FLOW TEST AND IT WAS FOUND THAT WAS FOUND THAT THE REGULATOR CLOSER WAS NOT SEATED PROPERLY. WHEN THE DEVICE DOOR IS CLOSED, THE REGULATOR OPENER OPENS THE CASSETTE FLOW REGULATOR CLOSER CLOSES THE CASSETTE FLOW REGULATOR. THE PROBABLE CAUSE FOR THE REGULATOR CLOSER TO BE NOT SEATED PROPERLY IS THAT DURING THE INSTALLATION OF FLUID SHIELD, IF THE FLUID SHIELD TAB IS NOT ALIGNED PROPERLY, IT WILL PUSH THE REGULATOR CLOSER AND CAUSE THE REGULATOR CLOSER TO DISENGAGE FROM THE CHASSIS POST. UPON CLOSING THE DOOR LEVER, THE REGULATOR CLOSER WILL DISLODGE AND MOVE TO THE FRONT OF THE CHASSIS POST. AS THE REGULATOR CLOSER IS NOT SNAPPED INTO POSITION ON ITS MATING POST ON THE MECHANISM CHASSIS, THE CASSETTE FLOW REGULATOR WILL NOT BE CLOSED RESULTING IN FREE FLOW WHEN THE DEVICE DOOR IS OPENED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DISTAL PRESSURE WAS OUT OF TOLERANCE AND THE DEVICE MECHANISM COULD NOT BE CALIBRATED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE DID NOT PASS THE UNRESTRICTED FLOW TEST AND IT WAS FOUND THAT THE REGULATOR CLOSER WAS NOT SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166056 PLM A+PMP W/BSE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA