BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 1593825 · Received February 2, 2010

    Report

    Report Number
    2921482-2010-00039
    Event Type
    Other
    Date Received
    February 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 4, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011442
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.1ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/-1ML (+/-5%). THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE MFG FACILITY. THE DEVICE HISTORY INDICATES THAT ON 01/01/2010, AT 0325, LINE A OF THE DEVICE WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER HEPARIN 2500 UNITS/250ML, (B)(6), WITH A DOSE OF 11 UNITS/KG/HR FOR A DURATION OF 2 HOURS 46 MINUTES, AND A RATE OF 90.2ML/HR, AND THE DELIVERY WAS STARTED. AT 0634, THE DEVICE ALARMED THAT THE DELIVERY ON LINE A WAS COMPLETE. AT 0636, LINE A WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER HEPARIN 2500 UNITS/250ML, (B)(6), WITH A DOSE OF 11 UNITS/KG/HR, FOR A DURATION OF 2 HOURS 46 MINUTES, AND A RATE OF 90.2ML/HR, AND THE DELIVERY WAS STARTED. AT 0820, THE DELIVERY WAS STOPPED WITH THE VOLUME INFUSED OF 404.6ML. AT 0825, LINE A WAS REPROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER HEPARIN 25000 UNITS/250ML, (B)(6), WITH A DOSE OF 11 UNITS/KG/HR, FOR A DURATION OF 5 HOURS 33 MINUTES, AND A RATE OF 9ML/HR, AND THE DELIVERY WAS STARTED. AT 0838, THE DELIVERY WAS STOPPED WITH A VOLUME INFUSED OF 406.5ML, AND THE DEVICE WAS TURNED OFF. A REVIEW OF THE DEVICE HISTORY INDICATED THE DEVICE DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. THE PT WAS BEING TREATED FOR ATRIAL FIBRILLATION. AT AN UNSPECIFIED TIME IN THE "EARLY MORNING," THE DEVICE WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER HEPARIN 25000 UNITS/250ML, WITH A DOSE OF 11 UNITS/KG/HR, AND VTBI (VOLUME TO BE INFUSED) OF 250ML, FOR A CALCULATED RATE OF 9ML/HR AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT DURING MORNING ROUNDS, THE NURSE REVIEWED THE DEVICE PROGRAMMING AND NOTED THE DEVICE HAD BEEN PROGRAMMED TO DELIVER A CONCENTRATION OF 2500 UNITS/250ML INSTEAD OF THE INTENDED CONCENTRATION OF 25000 UNITS/250ML. THIS RESULTED IN A CALCULATED RATE OF 90ML/HOUR INSTEAD OF THE INTENDED RATE OF 9ML/HR. THE DELIVERY WAS STOPPED. THE PHYSICIAN WAS NOTIFIED AND ORDERED THE PT TO HAVE PTT (PARTIAL THROMBOPLASTIN TIME) AND INR (INTERNATIONAL NORMALIZED RATIO) LEVELS DRAWN. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED AT AN UNSPECIFIED TIME LATER USING A REPLACEMENT DEVICE. NO FURTHER MEDICAL INTERVENTIONS WERE REQUIRED. DURING A REVIEW OF THE DEVICE HISTORY, THE CUSTOMER INDICATED THAT THE EVENT WAS A RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE CONCENTRATION OF THE HEPARIN. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+PMP W/BSE MOD 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R PLUM A+ SOFTWARE MODULE, LIST #12097,(B)(4)| HEPARIN, MFG BY HOSPIRA INC.