BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP025369 DE LEIPZIG

    MDR report key: 2209629 · Received August 3, 2011

    Report

    Report Number
    1718850-2011-00092
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D905 EOS OXYGENATOR. THE 501(K) NUMBER FOR THE D905 EOS OXYGENATOR IS K043323. THE OXYGENATOR IS A COMPONENT OF THE (B)(4) CUSTOM HEART LUNG PACK. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT BLOOD WAS SEEN IN THE WATER LINE FROM THE HEAT EXCHANGER AT THE END OF THE CASE. THERE WAS NO REPORT OF PT INJURY. THE OXYGENATOR HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR EVAL. THE INVESTIGATION IS IN PROCESS. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT BLOOD WAS SEEN IN THE WATER LINE FROM THE HEAT EXCHANGER AT THE END OF THE CASE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP025369 DE LEIPZIG CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 110314001

    Patients

    Seq Age Sex Outcome Treatment
    1