BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINAI HSP BALTIMORE MD 1

    MDR report key: 2159565 · Received July 6, 2011

    Report

    Report Number
    1718850-2011-00067
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APEX OXYGENATOR AND THE 510(K) NUMBER IS K083021. THE OXYGENATOR IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST REPORTED THAT DURING PRIMING OF THE HEART/LUNG CIRCUIT, SHE NOTED A LEAK FROM THE BOTTOM OF THE OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT PRIOR TO ANY PATIENT INVOLVEMENT. THE APEX MEMBRANE MODULE WAS RETURNED TO SORIN GROUP (B)(4) INITIAL LEAK TESTING FOUND COMMUNICATION BETWEEN THE BLOOD AND WATER COMPARTMENTS IN THE OXYGENATOR. THE APEX OXYGENATOR HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR FURTHER ANALYSIS. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT DURING PRIMING OF THE HEART/LUNG CIRCUIT, SHE NOTED A LEAK FROM THE BOTTOM OF THE OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINAI HSP BALTIMORE MD 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 10046000028

    Patients

    Seq Age Sex Outcome Treatment
    1