BEUDAMED
    FDA Adverse Event Other Summary report: N

    D905 DIDECO EOS SINGLE HVR

    MDR report key: 3391057 · Received September 25, 2013

    Report

    Report Number
    1718850-2013-00200
    Event Type
    Other
    Date Received
    September 25, 2013
    Date of Event
    August 27, 2013
    Report Date
    August 28, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D905 DIDECO EOS SINGLE HVR. THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES AND THEREFORE HAS NO 510(K) NUMBER. HOWEVER, IT IS SIMILAR TO THE D905 EOS HOLLOW FIBER OXYGENATOR WHICH IS DISTRIBUTED IN THE UNITED STATES. THE 510(K) NUMBER FOR THE D905 EOS HOLLOW FIBER OXYGENATOR IS K043323. THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT OF A BLOOD LEAK FROM THE DIDECO D905 DIDECO EOS SINGLE HVR DURING A PROCEDURE. THE CLINICIAN REPLACED THE OXYGENATOR WITH ANOTHER AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE REPLACEMENT TOOK APPROXIMATELY FIVE MINUTES. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A BLOOD LEAK FROM THE DIDECO D905 DIDECO EOS SINGLE HVR DURING A PROCEDURE. THE CLINICIAN REPLACED THE OXYGENATOR WITH ANOTHER AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483795 D905 DIDECO EOS SINGLE HVR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1301100145

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR