BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA HOSPIRA MEDNE

    MDR report key: 2093263 · Received April 14, 2011

    Report

    Report Number
    9615050-2011-00250
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING BY DELIVERING A DOSE WHEN THE PT PENDANT WAS PRESSED. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER IN THE PCA ONLY MODE, HYDROMORPHONE 0.2MG/ML, WITH A 0.3MG PCA DOSE, AND AN 8 MIN PT LOCKOUT. IMMEDIATELY AFTER THE PUMP WAS PROGRAMMED, THE PT PRESSED THE PT PENDANT. IT WAS REPORTED THAT THE PUMP DID NOT BEEP AS EXPECTED WHEN THE PT PENDANT WAS PRESSED AND THAT THE PUMP HAD "NO REACTION." IT WAS REPORTED THAT THE NURSE CHECKED THE PT PENDANT AND THE PENDANT JACK CONNECTION AND REPORTED THAT THE CONNECTION WAS "TIGHT AND SCREWED IN WELL." THE PT THEN PRESSED THE PT PENDANT AGAIN; HOWEVER, A DOSE WAS NOT DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED WITHIN TWO MINS USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA HOSPIRA MEDNE 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR