BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS

    MDR report key: 15437428 · Received September 16, 2022

    Report

    Report Number
    15437428
    Event Type
    Death
    Date Received
    September 16, 2022
    Date of Event
    August 20, 2022
    Report Date
    August 23, 2022
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ICU PATIENT ON VERY HIGH EPI/NOREPI/VASO FOR HEMORRHAGIC SHOCK. ALARIS PUMP ALARMED DISCHARGED BATTERY AND IMMEDIATELY TURNED OFF, NO PRIOR BATTERY ALARMS NOTICED. NURSE ATTEMPTED TO RESTART DRIPS, HAD TO WAIT GOT PUMPS TO TURN ON AND COMPLETELY RESTART. TOOK LESS THAN A MINUTE, HOWEVER IN THAT TIME PATIENT BLOOD PRESSURE LOST AND WAS NOT ABLE TO GET IT BACK. EPI TAKEN TO 1 MCG/KG/MIN AND VASOPRESSIN INCREASED TO 1.6 MILL-UNITS/KG/MIN WITH LITTLE IMPROVEMENT. PUSH PULL STARTED; HEARTRATE DECREASED SIGNIFICANTLY. PULSE NOT DETECTED. PATIENT WAS A FULL AND PRIOR TO THIS EVENT. PER DISCHARGE SUMMARY: ON EPINEPHRINE, NOREPINEPHRINE, AND VASOPRESSIN FOR HYPOTENSION ON EXTREMELY HIGH DOSES (0.6 MCG/KG/MIN , 0.8 MCG/KG/MIN AND 0.6 MILI-UNITS/KG/MIN RESPECTIVELY ) WERE THE LOWEST ABLE TO ACHIEVE PRIOR TO HIS DEMISE. ALL ALARIS DEVICES ARE ON SOFTWARE VERSION 9.33, WE HAVE NOT UPGRADED TO V12. MANUFACTURER RESPONSE FOR PUMP, INFUSION, ALARIS (PER SITE REPORTER). MANUFACTURER RESPONSE FOR PUMP, INFUSION, ALARIS SYRINGE PUMP, MODEL 8100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221846 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 9490 DA Male Death