BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSION PACK, MEDICAL CENTER HOSP, CONROE, TX

    MDR report key: 185963 · Received September 3, 1998

    Report

    Report Number
    1718850-1998-00010
    Event Type
    Malfunction
    Date Received
    September 3, 1998
    Date of Event
    August 10, 1998
    Report Date
    August 10, 1998
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LEAK OCCURRED AT THE REDUCING CONNECTOR ON THE POSITIVE PRESSURE SIDE OF THE PUMP BOOT. THE LEAK STARTED APPROX 1 MIN AFTER AORTIC CROSS CLAMPING WAS INITIATED AND SQUIRTED BLOOD FOR ABOUT 40 SECONDS BEFORE THE PERFUSIONIST WAS ABLE TO ATTACH A TIE-BAND TO THE CONNECTOR AND STOP THE LEAK. THE PERFUSIONIST ESTIMATED THAT 250 CC OF BLOOD WAS LOST DUE TO THE LEAK. AFTER THE LEAK WAS FIXED THE REMAINING PORTION OF THE SURGERY RAN SMOOTHLY. NO BLOOD OR DRUGS WERE GIVEN AS A RESULT OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION PACK, MEDICAL CENTER HOSP, CONROE, TX CUSTOM PERFUSION PACK DWE COBE CARDIOVASCULAR, INC. NA 05D0458

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other