BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVECOR

    MDR report key: 41477 · Received September 18, 1996

    Report

    Report Number
    2026191-1996-00044
    Event Type
    Death
    Date Received
    September 18, 1996
    Date of Event
    September 2, 1996
    Report Date
    September 17, 1996
    Manufacturer
    AVECOR, INC.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BABY WAS PLACED ON ECMO ONE DAY POST OPERATION FOR HYPOPLASTIC LEFT HEART SYNDROME. PRESSURE DIFFERENCE PRE- AND POST-OXYGENATOR MEMBRANE ROSE TO 300 MMHG; LATER TO 500 MMHG. ACT'S WERE 180-220 SECONDS PER PROTOCOL. INSPECTION OF THE OXYGENATOR DID NOT REVEAL ANY SHIFTING OF THE MEMBRANE. THE BABY DID NOT IMPROVE WITH ECMO SUPPORT AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVECOR OXYGENATOR DTZ AVECOR, INC. 0800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Death