BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC 32 FRENCH CRESCENT CANNULA

    MDR report key: 12779322 · Received November 8, 2021

    Report

    Report Number
    MW5105171
    Event Type
    Death
    Date Received
    November 8, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 5, 2021
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ECMO CANNULA (AT 50 DAYS) DEVELOPED A HAIRLINE CRACK WHICH ALLOWED AIR TO BE ENTRAINED IN THE SYSTEM. WHEN THE BUBBLE DETECTOR ALARMED THE PERFUSIONIST CONTACTED THE PHYSICIAN WHO CAME AND TOOK PATIENT TO OPERATING ROOM TO CHANGE OUT. PATIENT ARRESTED DURING THIS TIME AND SUFFERED AN ANOXIC BRAIN INJURY. WAS RESUSCITATED SUCCESSFULLY. PATIENT'S FAMILY WITHDREW CARE ON (B)(6) 2021 AND PATIENT PASSED. MEDTRONIC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665236 MEDTRONIC 32 FRENCH CRESCENT CANNULA DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70132 2102173

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other| D ALBUTEROL-IPRATROPIUM| ATIVAN| CEFEPIME| EPINEPHRINE| GABAPENTIN| HEPARIN| INSULIN| LASIX| MELATONIN| MILRINONE| OCULAR LUBRICANT| PEPCID| REMERON| SODIUM CHLORIDE INHALATION| VENELEX| ZOFRAN | ZYPREXA