BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2963378 · Received February 11, 2013

    Report

    Report Number
    2963378
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    February 11, 2013
    Manufacturer
    CARDINAL HEALTH 200, LLC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BEING RECOVERED IN CV RECOVERY ROOM FROM AN OPEN AAA SURGERY. PATIENT WAS VERY HEMODYNAMICALLY UNSTABLE WITH BLOOD PRESSURES LITERALLY FROM THE 50'S TO 250 SYSTOLIC, REQUIRING MULTIPLE IV DRIPS TO BE STARTED, STOPPED, AND TITRATED. DURING A PERIOD OF TIME THE PATIENT'S SYSTOLIC BP WAS APPROXIMATELY 60. I WAS TRYING TO START AN EPINEPHRINE DRIP AND THE IV CHANNEL (WHICH I HAD ALREADY BEEN USING FOR ANOTHER DRIP EARLIER) SUDDENLY ALARMED THAT IT WAS DISCONNECTED AND SHUT DOWN. AFTER RESTARTING/RECONNECTING IT I ATTEMPTED TO AGAIN START THE EPINEPHRINE DRIP. THIS TIME ALL THE CHANNELS FAILED AND THE ENTIRE PUMP AND ALL THE CHANNELS JUST TURNED OFF COMPLETELY. WE HAD ANOTHER IV PUMP IN THE ROOM BUT ALL DRIPS HAD TO BE REMOVED AND SWITCHED OVER TO THE OTHER PUMP, DELAYING CARE OF THE BLOOD PRESSURE ON THIS FRESH UNSTABLE PATIENT FOR AT LEAST 5 MINUTES. PUMP AND CHANNELS WERE SENT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60209 ALARIS PUMP, INFUSION FRN CARDINAL HEALTH 200, LLC. 8100 *
    60210 ALARIS PUMP, INFUSION FRN CARDINAL HEALTH 200, LLC. 8100 *
    60211 ALARIS PUMP, INFUSION FRN CARDINAL HEALTH 200, LLC. 8100 *
    60212 ALARIS PUMP, INFUSION FRN CARDINAL HEALTH 200, LLC. 8100 *
    60213 ALARIS IV PUMP PUMP, INFUSION FRN CARDINAL HEALTH 200, LLC. 8100 *
    60214 ALARIS PUMP, INFUSION FRN CARDINAL HEALTH 200, LLC. 8100 *
    60415 ALARIS PUMP, INFUSION FRN CARDINAL HEALTH 200, LLC. 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR