BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 2222991 · Received August 10, 2011

    Report

    Report Number
    9615050-2011-00600
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 19, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS AL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DEMEROL. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. PRIOR TO CONNECTING THE DEVICE TO THE PT, THE NURSE PRESSED THE PT PENDANT; HOWEVER, A DOSE WAS NOT DELIVERED. THE CUSTOMER CONTACT REPORTED, IT IS THE USER FACILITY'S PROTOCOL FOR THE NURSE TO VERIFY DELIVERY PRIOR TO ATTACHING THE DEVICE TO THE PT. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS INITIATED USING A REPLACEMENT DEVICE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL 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 NA