BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC PERFUSION CANNULA

    MDR report key: 46280 · Received November 1, 1996

    Report

    Report Number
    1713910-1996-00025
    Event Type
    Malfunction
    Date Received
    November 1, 1996
    Date of Event
    September 16, 1996
    Report Date
    November 1, 1996
    Manufacturer
    RESEARCH MEDICAL INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE CABG PROCEDURE THE T-CONNECTOR CRACKED ON A HEPARIN COATED AORTIC PERFUSION CANNULA. THE PT REQUIRED A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC PERFUSION CANNULA PERFUSION CANNULA DWF RESEARCH MEDICAL INC. NA 80267

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other