BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA PLS II

    MDR report key: 2152664 · Received June 24, 2011

    Report

    Report Number
    9615050-2011-00455
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 3, 2011
    Manufacturer
    HOSPIRA COSTA RICA, LTD.
    Product Code
    FRN
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER 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. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF MORPHINE, IN THE PCA ONLY MODE, WITH A 2MG PCA DOSE, A 12 MINUTE PT LOCKOUT, AND A 20 MG 4 HOUR DOSE LIMIT. THE CUSTOMER CONTACT REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT PRESSED THE PT PENDANT; HOWEVER, A DOSE WAS NOT DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SVC. 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. AFTER THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR TESTING, IT WAS REPORTED THAT THE THREADS OF THE PT PENDANT JACK WERE BROKEN OFF WHICH DID NOT ALLOW A PT PENDANT TO BE SCREWED INTO THE JACK. IT WAS REPORTED THAT AFTER THE PT PENDANT JACK WAS REPLACED, THE DEVICE PASSED DELIVERY ACCURACY TESTING; HOWEVER, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PLS II 80FRN FRN HOSPIRA COSTA RICA, LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK