BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 2191091 · Received July 25, 2011

    Report

    Report Number
    9615050-2011-00564
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.2 ML FROM AN EXPECTED DELIVERY OF 20 ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/- 1ML (+/- 5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CTR. A REVIEW OF THE DEVICE HISTORY INDICATES THAT ON (B)(6) 2011 AT 1844, LINE A WAS PROGRAMMED TO DELIVER AT A RATE OF 250ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 250ML, FOR A DURATION OF 1 HOUR AND THE DELIVERY WAS STARTED. AT 1944, THE DEVICE ALARMED FOR N161 LINE A VTBI COMPLETE, WITH A VI (VOLUME INFUSED) OF 250ML. AT 1947, LINE B WAS PROGRAMMED IN THE PIGGYBACK MODE, TO DELIVER AT A RATE OF 100ML, WITH A VTBI OF 100ML, FOR A DURATION OF 1 HOUR, AND THE DELIVERY WAS STARTED. AT 2043, THE DELIVERY LINE B WAS STOPPED WITH A VI OF 94.3ML AND LINE B WAS REPROGRAMMED WITH A VTBI OF 100ML AND THE DELIVERY WAS RESTARTED. AT 2044, THE DEVICE ALARMED FOR N188 (PROXIMAL OCCLUSION B - AIR). AT 2045, THE DELIVERY ON LINE B WAS RESTARTED, STOPPED, AND THE DEVICE WAS TURNED OFF. 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. LINE B OF THE DEVICE WAS PROGRAMMED IN THE PIGGYBACK MODE, TO DELIVER AN UNSPECIFIED ANTIBIOTIC, FOR A DURATION OF ONE HOUR. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROX ONE HOUR, THE NURSE NOTED THE LINE A WAS DELIVERING, HOWEVER, THE ANTIBIOTIC ON LINE B HAD NOT BEEN DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WAS 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 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR LIST # 12097, SN (B)(4)| PLUM A+ SOFTWARE MODULE: