BEUDAMED
    FDA Adverse Event Death Summary report: N

    BENTLEY

    MDR report key: 71727 · Received August 9, 1996

    Report

    Report Number
    71727
    Event Type
    Death
    Date Received
    August 9, 1996
    Date of Event
    July 2, 1996
    Report Date
    August 9, 1996
    Manufacturer
    BAXTER-BENTLEY
    Product Code
    DWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TUBING CONNECTED TO HEART LUNG MACHINE BACKWARDS ALLOWING AIR TO BE PUMPED TO PT. NO PREVENTION MECHANISM BUILT INTO TUBING. NEW PROCEDURE IMPLEMENTED TO PREVENT FUTURE EVENTS: TUBING END TO BE IMMERSED IN WATER BEFORE ATTACHING TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENTLEY HL TUBING DWE BAXTER-BENTLEY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death