BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION HOLLOW FIBER OXYGENATOR

    MDR report key: 2026564 · Received February 18, 2011

    Report

    Report Number
    1718850-2011-00011
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DTZ
    PMA / PMN Number
    K023381
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISION HF OXYGENATOR ((B)(4)) IS A DEVICE THAT WAS MFG BY (B)(4). THE 501(K) NUMBER IS K080708. IN (B)(6) 2010, SORIN GROUP (B)(4) ACQUIRED (B)(4). IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS A BLOOD LEAK FROM THE VENT PORT OF THE OXYGENATOR. THE CASE WAS AN EMERGENCY ANEURYSM RUPTURE WHICH RESULTED IN THE PT LOSING A LOT OF BLOOD. THE BLOOD LOSS AMOUNT IS UNK. THE UNIT WAS CHANGED. IT WAS REPORTED THAT THE PT IS FINE. THE HOSP HAS RETAINED THE PRODUCT. THE (B)(4) HAS NOT BEEN RETURNED FOR EVAL. (B)(4) OPERATIONS HAVE BEEN DISCONTINUED. MFG PERSONNEL ARE NO LONGER AVAILABLE. WITHOUT THE PHYSICAL DEVICE FOR EVAL, THE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THAT THE OXYGENATOR CHANGE OUT TOOK APPROXIMATELY 3.5-4 MINUTES. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THE LENGTHY OXYGENATOR CHANGE OUT TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THERE WAS A BLOOD LEAK FROM THE VENT PORT OF THE OXYGENATOR. THE CASE WAS AN EMERGENCY ANEURYSM RUPTURE WHICH RESULTED IN THE PT LOSING A LOT OF BLOOD. THE BLOOD LOSS AMOUNT IS UNK. THE UNIT WAS CHANGED OUT. THERE WERE NO PT COMPLICATIONS DUE TO THE BLOOD LEAK. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ GISH BIOMEDICAL, INC. NA 210029

    Patients

    Seq Age Sex Outcome Treatment
    1