BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERFUSION PACK, OPTIMA XP 4000 VVR, FMC/PRESBYTERIAN, PHILAD

    MDR report key: 461296 · Received May 15, 2003

    Report

    Report Number
    1718850-2003-00009
    Event Type
    Other
    Date Received
    May 15, 2003
    Date of Event
    April 15, 2003
    Report Date
    May 15, 2003
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE CARDIOPULMONARY BYPASS PROCEDURE, THE PERFUSIONIST NOTED A BLOOD LEAK FROM THE WYE CONNECTOR PROXIMAL TO THE RETROGUARD FILTER. THE MEDICAL PERSONNEL REMOVED THE PT FROM BYPASS MOMENTARILY TO REPLACE THE CONNECTOR. THE PERFUSIONIST CUT THEMSELF IN THE PROCESS OF REMOVING THE CONNECTOR. THE PT WAS OFF BYPASS FOR APPROXIMATELY 90 SECONDS. THERE WAS MINIMAL BLOOD LOSS AND NO PT DETRIMENT THAT RESULTED FROM THIS INCIDENT. THE MEDWATCH IS BEING FILED PRIMARILY DUE TO THE PERFUSIONIST INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION PACK, OPTIMA XP 4000 VVR, FMC/PRESBYTERIAN, PHILAD CUSTOM PERFUSION PACK DWE COBE CARDIOVASCULAR, INC. NA 0305600092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other