BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GISH SPBC14-BR

    MDR report key: 34347 · Received June 6, 1996

    Report

    Report Number
    34347
    Event Type
    Malfunction
    Date Received
    June 6, 1996
    Date of Event
    May 1, 1996
    Report Date
    June 4, 1996
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUR DEVICES LEAKED BLOOD CARIOPLEGIA AT THE WATER OUTLET. DATE OF EVENT 5/1 - 31/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GISH SPBC14-BR 4:1 CARDIOPLEGIA DELIVERY SYSTEM DWE GISH BIOMEDICAL, INC. 058614

    Patients

    Seq Age Sex Outcome Treatment
    1 *