BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOLYTH

    MDR report key: 285241 · Received July 7, 2000

    Report

    Report Number
    285241
    Event Type
    Injury
    Date Received
    July 7, 2000
    Date of Event
    May 5, 2000
    Report Date
    May 31, 2000
    Manufacturer
    SORIN BIOMEDICAL, INC.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PERFUSION, PT'S OXYGEN SATURATION STARTED TO DROP, BLOOD GASES WERE SENT. THE OXYGENATOR WAS CHANGED. THE SYSTEM DOES NOT HAVE A MECHANISM (ALARM) TO INDICATE THAT THE OXYGENATOR MAY NOT BE OPERATING PROPERLY. SHOULD THERE BE SOME TYPE OF SENSOR OR WARNING TO THE PRACTITIONER OPERATING THE EQUIPMENT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOLYTH OXYGENATOR DTZ SORIN BIOMEDICAL, INC. UNK 994734

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R