BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOLLISTER - ANCHOR FAST ORAL ET TUBE FASTENER

    MDR report key: 17019793 · Received May 26, 2023

    Report

    Report Number
    MW5117945
    Event Type
    Death
    Date Received
    May 26, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 24, 2023
    Manufacturer
    HOLLISTER INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT #3-76 YEAR-OLD FEMALE SEEN IN THE ED ON (B)(6) 2023 WITH HYPOTENSION/ SHOCK SEPSIS AND PMH OF ESRD ON HD, DM, CAD (STENT IN 2017) GI BLEED, PE AND FEM-POP BYPASS WITH AKA RIGHT LIMB 3/23. SHE WAS RECEIVED FROM THE HD CENTER DUE TO HYPOTENSION. PERVIOUS 2 MISSED HD SESSIONS. BRADEN SCORE- 9. CXR NOTED DIFFUSE INFILTRATES/CHF/PULMONARY EDEMA. TREATED WITH ANTIBIOTICS AND VASOPRESSORS. ELEVATED TROPONINS NOTED- POSSIBLE NSTEMI. NOTED EPISODES OF V TACH WITH ARREST ON (B)(6) 2023 INTUBATED WITH 7.5 ET TUBE. NON- RESPONSIVE BUT REVIVED. FAMILY MADE PATIENT DNR. STARTED ON CVVHD BUT CONTINUED TO DECLINE. PRONOUNCED DECEASED ON (B)(6) 2023 AT 12;30 PM. FAMILY VS. DECEASED FOR A PERIOD OF 2 HOURS PER RN. ET TUBE REMOVED AND NOTED FACIAL SKIN TEARS ON LEFT (FULL CIRCLE OF DEVICE) AND SMALLER SKIN TEAR ON RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31646 HOLLISTER - ANCHOR FAST ORAL ET TUBE FASTENER DEVICE, FIXATION, TRACHEAL TUBE CBH HOLLISTER INC. 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death| O