BEUDAMED
    FDA Adverse Event Other Summary report: N

    D905 DIDECO EOS PHISIO

    MDR report key: 1812540 · Received August 18, 2010

    Report

    Report Number
    1718850-2010-00143
    Event Type
    Other
    Date Received
    August 18, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K043323
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THIS D905 EOS OXYGENATOR. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST NOTED THAT, PRIOR TO CROSS CLAMP, THE D905 EOS DEVICE WAS NOT OXYGENATING THE BLOOD. TO DATE, SORIN GROUP (B)(4) HAS NOT RECEIVED THE OXYGENATOR FOR EVALUATION. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. IT WAS REPORTED THAT THE PATIENT RECEIVED TWO UNITS OF BLOOD TO COMPENSATE FOR THE LOSS OF BLOOD WHEN THE CIRCUIT WAS REPLACED. IN ADDITION, THE HOSPITAL REPORTED THIS INCIDENT TO THE (B)(4). THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THESE ACTIONS.

    Description of Event or Problem · 1

    THE PERFUSIONIST NOTED THAT, PRIOR TO CROSS CLAMP, THE D905 EOS DEVICE WAS NOT OXYGENATING THE BLOOD. GAS AND SAMPLE LINES WERE CHECKED. NO ISSUES WERE FOUND. THE FIO2 WAS INCREASED FROM 65% TO 100% BUT THE PO2S REMAINED LOW. THE PT'S HEART WAS STILL BEATING. THE PROCEDURE WAS DISCONTINUED AND THE ENTIRE CIRCUIT WAS CHANGED OUT. TWO UNITS OF BLOOD WERE GIVEN TO COMPENSATE FOR THE BLOOD LOSS IN THE CIRCUIT. THE PROCEDURE CONTINUED WITHOUT INCIDENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D905 DIDECO EOS PHISIO D905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES DTZ SORIN GROUP ITALIA NA 0910060017

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR