BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUBING SET FOR CARDIOPLEGIA

    MDR report key: 382987 · Received March 8, 2002

    Report

    Report Number
    382987
    Event Type
    Other
    Date Received
    March 8, 2002
    Date of Event
    February 26, 2002
    Report Date
    March 8, 2002
    Manufacturer
    CHASE MEDICAL
    Product Code
    DWF
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2002, DURING A MITRAL VALVE AND CORONARY BYPASS GRAFT SURGERY THE OR EXPERIENCED PROBLEMS WITH THE MULTIPLE PERFUSION SET CAME APART AT THE CONNECTION SITE OF THE FOUR TUBINGS AND PT LOST 200-300 CC BLOOD ON THE FLOOR. PERFUSION SET IS PART OF A CARDIAC PACK SET PREPARED BY ALLEGIANCE TUBING SET IS FROM CHASE MEDICAL. STAFF RECALLS THAT THIS HAS HAPPENED 3-4 TIMES BEFORE BUT CANNOT REMEMBER THE PT NAMES. ALL PRODUCTS HAVE BEEN PULLED FROM THE CARDIAC PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBING SET FOR CARDIOPLEGIA * DWF CHASE MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other