BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICU MEDICAL MONITOR KIT

    MDR report key: 4995380 · Received August 14, 2015

    Report

    Report Number
    4995380
    Event Type
    Death
    Date Received
    August 14, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 22, 2015
    Manufacturer
    ICU MEDICAL
    Product Code
    DRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PATIENT ASSESSED DUE TO MONITOR ALARMING 5: 55P. LARGE AMOUNT OF BLOOD NOTED FROM FEMORAL INTRODUCER DUE TO STOPCOCK/BLUE PRESSURE CAP DISCONNECT. PATIENT WENT INTO PEA ARREST AND CPR STARTED. RETURN OF SPONTANEOUS CIRCULATION FOLLOWING ACLS. BLOOD PRODUCTS REQUIRED. PATIENT HAD A SECOND ARREST AND COULD NOT BE RESUSCITATED. CEASED TO BREATH AT 10:13 PM. REF MFR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537597 ICU MEDICAL MONITOR KIT FLUSH DEVICE: 46111-18 DRS ICU MEDICAL 46111-18

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death