BEUDAMED
    FDA Adverse Event Death Summary report: N

    HORIZON NXT

    MDR report key: 1404112 · Received June 17, 2009

    Report

    Report Number
    1641965-2009-00012
    Event Type
    Death
    Date Received
    June 17, 2009
    Date of Event
    May 16, 2009
    Report Date
    May 19, 2009
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K904518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP EVALUATION RESULTS: THE PUMP'S OPERATION LOG WAS REVIEWED. THE LOG SHOWS THAT ON THE EVENT DAY AT 15:41, THE DOSE MODE WAS SET FOR PROPOFOL. THE PUMP WAS FIRST STARTED AT A PROGRAMMED RATE OF 10.7ML/HR, VOLUME TO BE DELIVERED (VTBD) 70ML. WITHIN THE SAME MINUTE, THE PUMP WAS PUT ON HOLD AND STARTED AT A PROGRAMMED RATE OF 7.1ML/HR. AT 15:43, THE PUMP WAS PUT ON HOLD AGAIN AND STARTED AT A PROGRAMMED RATE OF 999.2ML/HR, VTBD 1000ML. AT 15:47, IT WAS PUT ON HOLD, VTBD AT THIS TIME WAS 929.3, SHOWING THAT 70.7ML OF DRUG SOLUTION HAD BEEN DELIVERED. THE LOG SHOWS THAT AT 15:51, THE RATE WAS PROGRAMMED TO 3.9ML/HR, VTBD 39.3 BUT THE PUMP WAS NOT STARTED AGAIN IN DOSE MODE SET FOR PROPOFOL. THE REPORTED OVERINFUSION COULD NOT BE REPRODUCED. B. BRAUN COMPLETED AN EVALUATION OF THE PUMP (NXT MODEL) PER PROCEDURE FOR COMPLAINT RETURNS. AS PART OF THE ROUTINE COMPLAINT TESTING REQUIREMENTS, THE RETURNED PUMP WAS TESTED FOR VOLUMETRIC ACCURACY A TOTAL OF SIX (6) TIMES, VOLUME TO BE DELIVERED IN EACH TEST: 5 ML (SPECIFICATIONS 4.75-5.25 ML). THREE TESTS AT 999 ML/HR HAD RESULTS OF 4.857 ML, 5.06 ML AND 4.84 ML. THREE TESTS AT 38 ML/HR HAD RESULTS OF 4.933 ML, 5.08 ML AND 4.94 ML. IN ADDITION, BASED ON THE INFORMATION FROM THE PUMP'S LOGS, THE FOLLOWING TESTING WAS PERFORMED: RATE 10.7ML/HR, VOLUME TO BE DELIVERED (VTBD) 1ML, DELIVERED 1.01ML; RATE 7.1ML/HR, VTBD 1ML, DELIVERED 0.98ML (DELIVERY SPECIFICATIONS FOR 1ML ARE 0.95-1.05); RATE 999.2ML/HR, VTBD 70.7ML, DELIVERED 72.1ML (DELIVERY SPECIFICATIONS FOR 70.7ML ARE 67.17-74.24); RATE 67.3ML/HR, VTBD 17.6ML, DELIVERED 17.7ML (DELIVERY SPECIFICATIONS FOR 17.6ML ARE 16.72-18.48). ALL RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    REPORTED OVERDOSING OF PROPOFOL. IT WAS REPORTED THAT THE NXT PUMP MAY HAVE BEEN INVOLVED WITH A PATIENT'S DEATH. INCIDENT MOST LIKELY OCCURRED IN 2009. AUTOPSY OF PATIENT OCCURRED IN THE NEXT DAY. THE PATIENT WAS FEMALE. DRUG BEING INFUSED WAS PROPOFOL. THE NASSAU COUNTY MEDICAL EXAMINER'S OFFICE HAS ORDERED A COPY OF THE MEDICAL RECORD. THE TOXICOLOGY REPORT FOR THE PATIENT IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON NXT INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death