BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTRACORPOREAL MEMBRANE OXYGENATION

    MDR report key: 21976005 · Received May 7, 2025

    Report

    Report Number
    MW5170005
    Event Type
    Death
    Date Received
    May 7, 2025
    Date of Event
    April 12, 2025
    Report Date
    May 2, 2025
    Manufacturer
    UNK
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 68 Y/O MALE ON PIRFENIDONE FOR IPF. UPON ROUTINE CHART REVIEW, PROVIDER NOTED PT ADMITTED (B)(6) 2025 FOR EXPEDITED LUNG TRANSPLANT EVALUATION, DEVELOPED DIC FROM ECMO COMPLICATIONS OF LIMB ISCHEMIA AND KIDNEY FAILURE, DECLARED INELIGIBLE FOR TRANSPLANT. PT AND FAMILY ELECTED DNR (DO NOT RESUSCITATE) AND COMFORT CARE. PT EXPIRED (B)(6) 2025 ON COMFORT MEASURES WITH FAMILY AT BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512632 EXTRACORPOREAL MEMBRANE OXYGENATION OXYGENATOR, CARDIOPULMONARY BYPASS DTZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death ALBUTEROL INHALER.| AMLODIPINE.| ASPIRIN. | ATENOLOL.| ATORVASTATIN.| ATROVENT NASAL SPRAY. | BENZONATATE.| BREYNA HFA.| CALCIUM CARBONATE.| FLONASE.| HYDROCHLOROTHIAZIDE. | MOTRIN. | MVI. | PANTOPRAZOLE. | POTASSIUM CHLORIDE. | SPIRIVA RESPIMAT.| ZOFRAN.