BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRANE OXYGENATOR

    MDR report key: 78322 · Received March 19, 1997

    Report

    Report Number
    78322
    Event Type
    Injury
    Date Received
    March 19, 1997
    Date of Event
    February 7, 1997
    Report Date
    February 18, 1997
    Manufacturer
    SARNS (3M) HEALTH CARE
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT THROMBOENDARTERECTOMY OF THE LEFT COMMON, INTERNAL AND EXTERNAL CAROTID ARTERIES AND CORONARY ARTERY BYPASS. DURING THE PROCEDURE, THE PT'S OXYGEN SATURATION DECREASED. PT WAS CONVERTED FROM HEART LUNG MACHINE TO ANESTHESIA MACHINE WITH IMPROVEMENT. IT WAS SUSPECTED THAT THE PT'S DECREASE IN OXYGEN SATURATION MAY HAVE BEEN RELATED TO THE FAILURE OF THE SYSTEM TO SCAVENGE WASTE GAS FROM THE MEMBRANE OXYGENERATOR WHILE THE PT WAS ON HEART LUNG BY-PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRANE OXYGENATOR SARNS TURBO MEMBRANE OXYGENATOR DTZ SARNS (3M) HEALTH CARE 9443 W347419
    2 Y CONNECTOR STERILE DISPOSABLE "X" "X" "Y" CONNECTOR CAC SURGIMEDICS (TMP) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability