BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 1883200 · Received October 20, 2010

    Report

    Report Number
    2921482-2010-00807
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 19.5ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20 ML (+/- 5%). BASED UPON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE MFR FACILITY. A REVIEW OF THE DEVICE HISTORY INDICATES ON (B)(6) 2010 AT 1456, LINE A WAS PROGRAMMED TO DELIVER AT A RATE OF 11.4ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 136ML, AND THE DELIVERY WAS STARTED. AT 0303 ON (B)(6) 2010, A VI (VOLUME INFUSED) OF 132.5ML WAS CLEARED. AT 0610, THE DELIVERY ON LINE A WAS COMPLETE. AT 0614, LINE A WAS REPROGRAMMED WITH A VTBI OF 11.4ML AND THE DELIVERY WAS STARTED. AT 0714, THE DELIVERY ON LINE A WAS COMPLETE AND LINE A WAS REPROGRAMMED TO DELIVER A VTBI OF 22.8ML AND THE DELIVERY WAS STARTED. AT 0914, THE DELIVERY ON LINE A WAS COMPLETE. AT 0920, LINE A WAS REPROGRAMMED WITH A VTBI OF 11.4ML AND THE DELIVERY WAS STARTED. AT 1020, THE DELIVERY ON LINE A WAS COMPLETE. AT 1022, LINE A WAS REPROGRAMMED WITH VTBI OF 11.4 AND THE DELIVERY WAS STARTED. AT 1048, THE DELIVERY WAS STOPPED WITH A VI OF 86.2ML. AT 1049, LINE A WAS REPROGRAMMED WITH A VTBI OF 6.5ML. LINE B WAS PROGRAMMED IN THE CONCURRENT MODE, TO DELIVER AT A RATE OF 8ML, WITH A VTBI OF 8ML, AND THE DELIVERIES WERE STARTED. AT 1105, THE DEVICE ALARMED N230 (PROX AIR, BACKPRIME. BETWEEN 1114 AND 1230, THERE WERE 12 ATTEMPTS TO BACKPRIME. AT 1230, LINE B DELIVERY WAS RESUMED. AT 1235, THE DEVICE ALARMED N231 (PROX AIR B, BACKPRIME). AT 1237, THE DEVICE ALARMED N102 INFUSER IDLE. AT 1240, THE DEVICE WAS TURNED OFF. A REVIEW OF THE DEVICE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE PATIENT RECEIVED MORE IV FLUID THAN INTENDED. ON (B)(6) 2010 AT 1800, THE PRIMARY LINE OF THE PUMP WAS PROGRAMMED TO DELIVER TOTAL PARENTERAL NUTRITION (TPN) AT A RATE OF 11.4ML/HR WITH A VTBI (VOLUME TO BE INFUSED) OF 300ML AND THE DELIVERY WAS STARTED. ON (B)(6) 2010 AT APPROXIMATELY 1600, THE NURSE NOTED THAT THERE WERE "ONLY A FEW CC'S LEFT" IN THE TPN CONTAINER WHICH WAS 3 HOURS EARLIER THAN EXPECTED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA, INC. NA NA

    Patients

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