BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV OF VA CHARLOTTESVILLE VA1

    MDR report key: 2108754 · Received April 20, 2011

    Report

    Report Number
    1718850-2011-00028
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE FILED IF THE INFO IS RECEIVED. SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR. THE 510(K) NUMBER OF THE PRIMO2X OXYGENATOR IS K050447. THE OXYGENATOR IS A COMPONENT OF THE CUSTOM HEART LUNG PACK. THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. TESTING OF THE DEVICE DID IDENTIFY A LEAK PATH BETWEEN THE BLOOD SIDE AND WATER SIDE OF THE HEAT EXCHANGER. THE OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER EVAL. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT AT THE END OF THE CASE, THE HEAT EXCHANGER WATER LINES WHICH HAD BEEN CLAMPED DURING THE PROCEDURE WERE UNCLAMPED IN ORDER TO RE-WARM THE PT. NO ISSUES WERE NOTED. AFTER THE CASE, DURING TEAR-DOWN, BLOODY WATER WAS NOTED COMING OUT OF THE OXYGENATOR HEAT EXCHANGER AS IT WAS REMOVED FROM THE BRACKET. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIV OF VA CHARLOTTESVILLE VA1 CUSTO PERFUSION PACK DWE SORIN GROUP USA, INC. NA 1101100058

    Patients

    Seq Age Sex Outcome Treatment
    1