BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS

    MDR report key: 6116602 · Received November 21, 2016

    Report

    Report Number
    6116602
    Event Type
    Death
    Date Received
    November 21, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 25, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN CRITICAL CONDITION WITH 3 VASOPRESSOR MEDICATIONS INFUSING VIA THE ALARIS PUMP. ONE OF THE PUMP CHANNELS INFUSING EPINEPHRINE SUDDENLY BEEPED AND SAID "CHANNEL DISCONNECT" AND SHUT DOWN. THE BEDSIDE NURSE WAS UNABLE TO GET THE CHANNEL TO WORK AGAIN. THE MEDICATION WAS SWITCHED TO ANOTHER ALARIS IV PUMP AND EPINEPHRINE WAS RESTORED TO THE PATIENT. IN THE TIME PERIOD THAT IT TOOK FOR THE EPINEPHRINE TO BE RESTARTED, THE PATIENT'S BLOOD PRESSURE DROPPED PRECIPITOUSLY. BLOOD PRESSURE WAS RESTORED AFTER 2 IV PUSHES OF EPINEPHRINE AND THE DRIP BEING RESTARTED. SEVERAL MINUTES LATER THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND SHE SUFFERED A CARDIAC ARREST. THE PATIENT REGAINED SPONTANEOUS CIRCULATION AFTER SEVERAL MINUTES OF CPR BUT THEN FAMILY THEN OPTED FOR DNR STATUS WITH NO ESCALATION OF CARE AND THE PATIENT ULTIMATELY EXPIRED. THE ATTENDING PHYSICIAN FEELS THAT THE PATIENT'S UNDERLYING CONDITION WAS THE CAUSE OF HER DEATH BUT ALSO THINKS THE PUMP MALFUNCTION MADE SOME CONTRIBUTION TO HER DETERIORATION. BIOMED TESTING: WE RECEIVED THIS PUMP THIS MORNING TAGGED FOR AN INCIDENT. THE PROBLEM DESCRIPTION IS "CHANNEL ERROR WHILE INFUSING DRUG, CHANNEL THEN SHUT DOWN." THIS IS ANOTHER CHECK IV SET ERROR CAUSED BY A BAD BOTTLE SIDE PRESSURE SENSOR VOLTAGE. THE ERROR LOG SHOWS MULTIPLE INSTANCES OF THIS ERROR (AT FATAL SEVERITY) THROUGHOUT THE MONTH. BASED ON THE RECORDS IN TMS, THIS PUMP HAS THE ORIGINAL PRESSURE SENSOR FROM THE FACTORY. THIS IS THE THIRD ERROR RELATED TO PRESSURE SENSOR FAILURES THAT WE HAVE HAD IN A WEEK. THIS IS ALSO NOT THE FIRST PUMP WITH THESE ERRORS THAT WE HAVE NOT GOTTEN NOTIFIED ABOUT AFTER THE INITIAL MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768427 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death NO