BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 2093258 · Received April 14, 2011

    Report

    Report Number
    9615050-2011-00251
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    March 17, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING OF THE DEVICE WAS CONDUCTED AT THE USER FACILITY BY THE FIELD SERVICE ENGINEER ON (B)(4) 2011. THE PT PENDANT WAS REC'D ON (B)(4) 2011. INVESTIGATION IS NOT COMPLETE. 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 THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. AT "SOMETIME IN THE AFTERNOON," THE DEVICE WAS PROGRAMMED IN THE PCA ONLY MODE TO DELIVER MORPHINE 1MG/ML. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT THIS TIME, THE NURSE GAVE THE PT THE PT PENDANT TO DELIVER A BOLUS DOSE. IT WAS REPORTED THAT AFTER THE PT PRESSED THE PT PENDANT, THE DEVICE DID NOT DELIVER A DOSE. THE NURSE REPORTED THAT AT THIS TIME, THE DEVICE WAS REPROGRAMMED TO DELIVER AN UNSPECIFIED LOADING DOSE AND THE LOADING WAS STARTED. THE NURSE REPORTED THAT AFTER THE LOADING DOSE WAS DELIVERED, THE PT PRESSED THE PT PENDANT AGAIN; HOWEVER, A DOSE WAS NOT DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED 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. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1