BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSION PACK, BLUE RIBBON W/UTUBE EMORY UNIVERSITY

    MDR report key: 539940 · Received March 23, 2004

    Report

    Report Number
    1718850-2004-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 9, 2004
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WERE NO PROBLEMS DURING THE PRIMING OF THE CIRCUIT. ONCE ON BYPASS, BLOOD STARTED SPRAYING FROM THE LUER FITTING AT THE TOP OF THE ARTERIAL FILTER. BLOOD HIT THE PERFUSIONIST. A STOPCOCK WAS INSTALLED TO BE ABLE TO CONTINUE TO USE THE CUSTOMER PERFUSION PACK. THE MALE LUER FITTING APPEARED TO BE CRACKED. BLOOD LOSS WAS MINIMAL AND NO INTERVENTION WAS REQUIRED TO COMPENSATE FOR THE BLOOD LOSS. THERE WAS NO PT DETRIMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION PACK, BLUE RIBBON W/UTUBE EMORY UNIVERSITY CUSTOMER PERFUSION PACK DWE COBE CARDIOVASCULAR, INC. NA NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other