BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP84042 DE LEIPZIG %

    MDR report key: 2108923 · Received April 20, 2011

    Report

    Report Number
    1718850-2011-00029
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 21, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWE
    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 510(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 AT (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE PERFUSIONIST SAW BLOOD IN THE WATER LINE AFTER ONE HOUR OF ECC. A SMALL AMOUNT OF BLOOD WAS NOTED COMING OUT OF THE WATER LINE CONNECTORS AFTER THEY WERE DISCONNECTED FROM THE OXYGENATOR WATER PORTS. 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 THE PERFUSIONIST SAW BLOOD IN THE WATER LINE AFTER ONE HOUR OF ECC. A SMALL AMOUNT OF BLOOD WAS NOTED COMING OUT OF THE WATER LINE CONNECTORS AFTER THEY WERE DISCOVERED FROM THE OXYGENATOR WATER PORTS. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP84042 DE LEIPZIG % CUSTOM PERFUSION PACK DWE SORIN GROUP ITALIA CP084042 1101190059

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR