BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GISH HARDSHELL VENOUS RESERVOIR

    MDR report key: 1925412 · Received November 9, 2010

    Report

    Report Number
    1925412
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 9, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING PLACED ON CARDIO-PULMONARY BYPASS (CPB). THE PRACTITIONER WAS UNABLE TO ACHIEVE ADEQUATE VENOUS RETURN FROM THE PT. INITIALLY AN ATTEMPT WAS MADE TO CHANGE THE VENOUS CANNULA AND THE VENOUS LINE BUT THE PROBLEM PERSISTED. THE DETERMINED RESERVOIR INFLOW PORT WAS PARTIALLY OBSTRUCTED. THE VENOUS RESERVOIR WAS CHANGED AND THE PROBLEM RESOLVED. ON EXAMINATION OF THE VENOUS RESERVOIR, IT WAS DETERMINED THAT A SMALL WHITE PLASTIC LUER CAP WAS LODGED WITHIN THE FLOW PATH OF MANUFACTURER'S SEALED PORT. THE CASE PROCEEDED WITHOUT FURTHER INCIDENT. HOWEVER, THE PT WAS PLACED ON AND OFF BY-PASS TWICE BEFORE A SUCCESSFUL CPB INITIATION. THIS EVENT IS CONSIDERED TO BE A MANUFACTURING DEFECT. OUR STAFF HAVE SPOKEN WITH SORIN (THE COMPANY THAT PURCHASED GISH) AND THEY WOULD LIKE TO HAVE THE PRODUCT RETURNED. THEY ARE SENDING A BIOHAZARD SHIPPING CONTAINER SO THAT THEY MAY INSPECT AND DISASSEMBLE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GISH HARDSHELL VENOUS RESERVOIR HARDSHELL VENOUS RESERVOIR DTN SORIN GROUP USA, INC. * 214014

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR NO OTHER THERAPIES