BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+ TRIPLE REFUR

    MDR report key: 1625097 · Received February 24, 2010

    Report

    Report Number
    2921482-2010-00078
    Event Type
    Other
    Date Received
    February 24, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 25, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 20ML+/- 1ML (+/- 5%). THE DEVICE PASSED TESTING FOR DISTAL AIR IN LINE BY APPROPRIATELY ALARMING WHEN AIR WAS PRESENT IN THE DISTAL LINE. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE MFR FACILITY. A REVIEW OF THE DEVICE HISTORY INDICATES THAT ON (B)(6) 2010 AT 2342, LINE A WAS PROGRAMMED FOR LOADING DOSE DELIVERY OF MILRINONE 20MG/100ML, WITH A DOSE OF 50 MCG/KG/MIN, WT 65 KG AND A VTBI (VOLUME TO BE INFUSED) OF 163ML FOR A DURATION OF 10 MIN., WITH A CALCULATED RATE OF 975ML/HR. WITHIN THE SAME MINUTE, DOSE LIMIT OVERRIDE MESSAGE OCCURRED, WAS ACCEPTED, AND DELIVERY WAS STARTED. AT 2348, THE DEVICE ALARMED N232 (PROX AIR A, BACKPRIME). AT 2349, DEVICE WAS TURNED OFF. A REVIEW OF 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 AN UNSPECIFIED OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. ADDITIONALLY, THE CUSTOMER REPORTED AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. THE PT WAS BEING TREATED IN THE ICU (INTENSIVE CARE UNIT) FOR HYPOTENSION, HYPOKALEMIA, DEHYDRATION AND WAS ON A CARDIAC MONITOR. AT APPROX 2345, CHANNEL 3 OF THE PUMP WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER MILRINONE 200 MCG/ML WITH A DOSE OF 50MCG/KG/MIN, WITH A WEIGHT OF 65KG FOR A LOADING DOSE OF 3250MCG AND THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT STATED THAT IT WAS EXPECTED THAT THE DEVICE WOULD DELIVER A TOTAL VOLUME OF 16.25ML. AT 2355, THE NURSE NOTED THE MILRINONE CONTAINER WAS EMPTY AND THAT THERE WAS APPROX 6 INCHES OF AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. NO AIR REACHED THE PT. THE DELIVERY WAS STOPPED. THE PHYSICIAN WAS NOTIFIED AND THE MILRINONE THERAPY WAS DISCONTINUED. NO FURTHER INTERVENTIONS WERE REQUIRED. THE PT WAS MONITORED FOR ARRHYTHMIA. THE PT HAD "MILD TACHYCARDIA" FOR 10-15 MINUTES. NO ARRHYTHMIA WAS REPORTED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE PT WAS TRANSFERRED OUT OF THE ICU ON AN UNSPECIFIED DAY AFTER THE EVENT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE FOR ADD'L INFO INCLUDING THE SPECIFIC OPERATOR ERROR IN PROGRAMMING. NO RESPONSE WAS RECEIVED. HOSPIRA IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention MILRINONE, MFG BY HOSPIRA INC.