BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA NEW 802.00 AB

    MDR report key: 3172049 · Received June 10, 2013

    Report

    Report Number
    9615050-2013-01568
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 17, 2013
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. THIS REPORT REPRESENT ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT WHILE OPERATING ON AC POWER, THE DEVICE POWERED OFF BY ITSELF WITHOUT SOUNDING AN AUDIBLE ALARM TONE. AT AN UNSPECIFIED TIME IN THE AFTERNOON, THE DEVICE WAS PROGRAMMED TO DELIVER MORPHINE 1MG/ML, IN THE PCA ONLY MODE, WITH A 2MG PCA DOES, A 10 MINUTE PT LOCKOUT, A 30MG 4 HOUR DOES LIMIT, AND THE DELIVERY WAS STARTED. IT WAS REPORTING THAT THE DEVICE WAS OPERATING ON AC POWER. AFTER A REPORTED SHORT TIME WHILE THE NURSE AS IN THE PT'S ROOM, IT WAS REPORTED THAT THE DEVICE POWERED OFF BY ITSELF WITHOUT SOUNDING AN AUDIBLE ALARM TONE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EVENTS 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
    261424 LC PCA NEW 802.00 AB 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1