BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIV OF VA CHARLOTTESVILLE VA1

    MDR report key: 1953466 · Received December 28, 2010

    Report

    Report Number
    1718850-2010-00181
    Event Type
    Other
    Date Received
    December 28, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    PMA / PMN Number
    K050447
    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. THE PRIMO2X OXYGENATOR IS MANUFACTURED BY SORIN GROUP (B)(4) AND IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE 510(K) NUMBER FOR THE PRIMO2X OXYGENATOR IS K050447. THIS INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE PRIMO2X OXYGENATOR WAS RETURNED FOR EVALUATION. 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 EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT AS THEY WERE INITIATING BYPASS, THEY NOTICED BLOOD IN THE WATER LINE. THE PRIMO2X OXYGENATOR WAS CHANGED OUT AND THE CASE PROCEEDED WITHOUT INCIDENT. THERE WAS NO REPORT OF PT INJURY. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIV OF VA CHARLOTTESVILLE VA1 CUSTOM PERFUSION PACK DWF SORIN GROUP ITALIA NA 1029300030

    Patients

    Seq Age Sex Outcome Treatment
    1