BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JOES/CLARES MARSHFIELD WI1

    MDR report key: 1739267 · Received June 25, 2010

    Report

    Report Number
    1718850-2010-00118
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    June 5, 2010
    Report Date
    June 7, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B) (4) MANUFACTURES THE PRIMO2X OXYGENATOR. THE OXYGENATOR IS APPROVED FOR DISTRIBUTION IN THE UNITED STATES. THE 510(K) NUMBER IS K050447. THE OXYGENATOR IS A COMPONENT OF THE HEART LUNG PERFUSION PACK. THE INCIDENT OCCURRED AT (B) (6) HOSPITAL IN (B) (6), (B) (6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B) (4). THE PERFUSIONIST REPORTED THAT DURING THE PROCEDURE. THE BLOOD COMING FROM THE OUTLET OF THE OXYGENATOR WAS BLACK. THE BLENDER AND THE GAS LINES WERE CHECKED BUT NO ISSUES WERE FOUND. THE UNIT WAS CHANGED OUT. THE PRIMO2X OXYGENATOR WAS RETURNED TO SORIN GROUP USA FOR EVAL. VISUAL INSPECTION DID NOT REVEAL ANY ABNORMALITIES. THE RETURNED OXYGENATOR WAS TESTED FOR OXYGEN AND CARBON DIOXIDE TRANSFER. A CONTROL UNIT WAS TESTED FOR COMPARISON. TEST RESULTS SHOWED THAT THE RETURNED DEVICE DID MEET PRODUCT SPECIFICATIONS WITH REGARD TO GAS EXCHANGE AND WAS COMPARABLE TO THE CONTROL UNIT. MANUFACTURING RECORDS SHOWED NO DEVIATIONS. THE DEVICE SUCCESSFULLY PASSED ALL IN-PROCESS TEST PROCEDURES PRIOR TO RELEASE. BASED ON THE ABOVE RESULTS, IT WAS CONCLUDED THAT THE RETURNED PRIMO2X OXYGENATOR WAS MANUFACTURED PROPERLY AND FOUND TO BE FUNCTIONALLY SOUND. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT TWENTY MINUTES AFTER ARRESTING THE HEART, BLOOD EXITING THE OXYGENATOR WAS BLACK. THE DEVICE WAS CHANGED OUT. THE PROCEDURE WAS AN ASCENDING AORTA DISSECTION REPAIR WITH A SINGLE CABG. THE DISSECTION RAN INTO ALL THREE HEAD VESSELS AND TO THE RENAL ARTERIES. IT WAS REPORTED THAT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JOES/CLARES MARSHFIELD WI1 CUSTOM PERFUSIOIN PACK DWE SORIN GROUP USA, INC. NA 1007400081

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death