BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISION HOLLOW FIBER OXYGENATOR

    MDR report key: 2121924 · Received June 1, 2011

    Report

    Report Number
    1718850-2011-00054
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 2, 2011
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DTZ
    PMA / PMN Number
    K080708
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA RECEIVED A REPORT OF AN INCREASE IN PRESSURE AT THE BLOOD INLET PORT OF A GISH HOLLOW FIBER OXYGENATOR DURING A CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE INCIDENT. NO MEDICAL INTERVENTION WAS REQUIRED. THE PRODUCT WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. WHEN THE UNIT WAS RECEIVED, IT HAD NOT BEEN RINSED AFTER USE AND A SIGNIFICANT AMOUNT OF TIME HAD ELAPSED SINCE THE DATE OF THE EVENT. THE FIBERS INSIDE THE MEMBRANE AND THE HEAT EXCHANGER WERE COATED WITH LARGE BLOOD CLOTS AND BLOOD RESIDUE, SOME OF WHICH HAD TURNED GREENISH IN COLOR. THE PRESSURE INCREASE REPORTED BY THE CUSTOMER COULD NOT BE REPRODUCED. THE PRESSURES RECORDED DURING TESTING WERE CONSISTENT WITH THOSE EXPECTED IN A USED OXYGENATOR. THE TESTING DID; HOWEVER, CONFIRM A COMMUNICATION BETWEEN THE BLOOD AND WATER SIDE COMPARTMENTS OF THE OXYGENATOR. FURTHER INSPECTION DETERMINED THAT THE COMMUNICATION BETWEEN THE COMPARTMENTS WAS CAUSED BY CORROSION OF THE HEAT EXCHANGER. THIS CORROSION IS BELIEVED TO HAVE BEEN CAUSED BY EXTENDED EXPOSURE OF THE HEAT EXCHANGER MATERIAL TO BLOOD AND OTHER FLUIDS DURING ITS RETURN. THE CAUSE OF THE PRESSURE INCREASES REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IT IS PROBABLE THAT CELLULAR ACTIVATION FROM THE SUCTIONED BLOOD, FLUID AND TISSUE FRAGMENTS, AND BIOLOGICAL AGGREGATES CONTRIBUTED TO THE INCREASED PRESSURE SEEN IN THE OXYGENATOR. THE VISION HOLLOW FIBER OXYGENATOR (HFO) WAS MANUFACTURED BY GISH BIOMEDICAL. IN (B)(6) 2010, SORIN GROUP USA ACQUIRED GISH BIOMEDICAL. THE DEVICE IN QUESTION WAS MANUFACTURED BY GISH BEFORE THE ACQUISITION. THIS PRODUCT LINE HAS BEEN DISCONTINUED, AND NO ADDITIONAL PRODUCT WILL BE MANUFACTURED. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT OF AN INCREASE IN PRESSURE AT THE BLOOD INLET PORT OF A GISH HOLLOW FIBER OXYGENATOR DURING A CASE. ABOUT 15 MINUTES INTO BYPASS, THEY FOUND THAT THE PRESSURE AT THE INLET OF THE HFO HAD INCREASED TO 360 MMHG WHILE THE PRESSURE AT THE OUTLET WAS 150 MMHG. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THE INCIDENT. THE OXYGENATOR WAS REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ GISH BIOMEDICAL, INC. NA 179029H

    Patients

    Seq Age Sex Outcome Treatment
    1