BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 1870884 · Received October 7, 2010

    Report

    Report Number
    2921482-2010-00765
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURE VOLUME OF 20.7 ML FROM AN EXPECTED DELIVERY OF 20 ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20 ML +/- 1 ML (+/- 5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE CUSTOMER CONTACT INDICATED THE EVENT WAS DUE TO AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY INDICATED THAT ON (B)(6) 2010 AT 1809, LINE A WAS PROGRAMMED WITH A RATE OF 100 ML/HR AND VTBI (VOLUME TO BE INFUSED) OF 1000 ML FOR A DURATION OF 10 HOURS, AND THE DELIVERY WAS STARTED. AT 1810, LINE B WAS PROGRAMMED IN THE CONCURRENT MODE WITH A RATE OF 1.3 ML/HR AND VTBI OF 49.9 ML FOR A DURATION OF 38 HOURS, 25 MINUTES AND THE DELIVERY WAS STARTED. AT 2116, LINE B WAS REPROGRAMMED WITH A RATE OF 1.4 ML AND THE DELIVERY WAS RESTARTED. AT 2135, LINE B WAS REPROGRAMMED WITH A RATE OF 1.3 ML/HR AND THE DELIVERY WAS RESTARTED. ON (B)(6) 2010 AT 0306, LINE A WAS PROGRAMMED WITH A RATE OF 100 ML AND VTBI OF 900 ML AND THE DELIVERY WAS STARTED, AND THE PROGRAMMING ON LINE B WAS CANCELLED. AT 0924, LINE A WAS REPROGRAMMED WITH A RATE OF 50 ML/HR AND VTBI OF 268.2 ML AND THE DELIVERY WAS STARTED. AT 1248, LINE A WAS REPROGRAMMED WITH A RATE OF 100 ML AND VTBI OF 1000 ML AND THE DELIVERY WAS STATED. AT 1249, LINE B WAS REPROGRAMMED WITH A RATE OF 1 ML/HR AND VTBI OF 26.1 ML AND THE DELIVERY WAS STARTED. AT 1434 THE DEVICE ALARMED WITH N230 (PROX AIR, BACKPRIME). THE SETTINGS ON LINE B WERE CLEARED. AT 1438, LINE B WAS PROGRAMMED IN THE PIGGYBACK MODE WITH A RATE OF 100 ML AND VTBI OF 30 ML, INSTEAD OF THE INTENDED RATE OF 1 ML/HR, AND THE DELIVERY WAS STARTED. AT 1455, THE DELIVERY ON LINE B WAS STOPPED. AT 1456, THE PROGRAMMING ON LINE B WAS CANCELLED, RESTARTED AT THE SAME RATE WITH A VTBI OF 0.5 ML, AND THE DELIVERY ON LINE B WAS STOPPED. AT 1458, LINE A WAS RESTARTED AT RATE OF 100 ML AND VTBI OF 824.3 ML. AT 1505, THE DELIVERY ON LINE A WAS STOPPED AND THE DEVICE WAS TURNED OFF. A REVIEW OF THE DEVICE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED. (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. ON (B)(6) 2010 AT 1806, THE LINE A OF DEVICE WAS PROGRAMMED TO DELIVER 5% DEXTROSE/0.45 SALINE, AT A RATE OF 100 ML/HR, AND THE DELIVERY WAS STARTED. ON (B)(6) 2010 BETWEEN 1700 AND 1800, LINE B WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER DILAUDID 50 MG/50 ML, AT A RATE OF 1.3 ML/HR, AND THE DELIVERY WAS STARTED. ON (B)(6) 2010 AT 1250, LINE B WAS REPROGRAMMED TO DELIVER THE DILAUDID AT A RATE OF 1 ML/HR AND THE DELIVERY WAS RESTARTED. THE CUSTOMER CONTACT INDICATED THAT IN ADDITION TO THE DILAUDID THERAPY, THE PT WAS ALSO WEARING A FENTANYL PATCH. AT APPROX 1500, THE NURSE NOTED THE PT WAS "DUSKY" AND WAS UNABLE TO SPEAK. THE PT HAD A BLOOD PRESSURE OF 195/122 MMHG, HEART RATE OF 139 BEATS PER MINUTE AND OXYGEN SATURATION OF 89% WHILE ON A NON-REBREATHER MASK WITH 15% OXYGEN. AT THIS TIME, THE NURSE NOTED THE DILAUDID CONTAINER WAS EMPTY AND THE DEVICE DISPLAYED THE RATE OF THE DILAUDID AS 100 ML/HR INSTEAD OF THE INTENDED RATE OF 1 ML/HR. THE PHYSICIAN WAS NOTIFIED AND THE PT WAS TREATED 4 TIMES WITH AN UNSPECIFIED CONCENTRATION OF NARCAN. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION. THE CUSTOMER CONTACT INDICATED THAT PT RESPONDED "REASONABLY WELL" TO TREATMENT. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE DILAUDID THERAPY WAS DISCONTINUED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING, INCLUDING DELIVERY ACCURACY. UPON REVIEW OF THE DEVICE HISTORY, THE CUSTOMER CONTACT INDICATED THE EVENT WAS A RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THOUGH REQUESTED, NO ADDITION INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R FENTANYL PATCH, MFR UNK| DILAUDID, MFG BY PURDUE PHARMACEUTICALS| PLUM A+ SOFTWARE MODULE:| LIST# 20791, (B)(4)