BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COD 712 TOP CIRC RACC CARDIO

    MDR report key: 1894613 · Received November 4, 2010

    Report

    Report Number
    1718850-2010-00163
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K992599
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THIS AUTOTRANSFUSION RESERVOIR. THE RESERVOIR IS A COMPONENT OF THE BLOOD COLLECTION SET. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FILTER DISCONNECTED FROM THE CARDIOTOMY RESERVOIR LID. SORIN GROUP (B)(4) HAS REQUESTED THAT PRODUCT BE RETURNED FOR EVALUATION. TO DATE, NO PRODUCT HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THE HOSPITAL REPORTED THIS INCIDENT TO THE COUNTRY COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE PROCEDURE, THE FILTER DETACHED FROM THE LID OF THE CARDIOTOMY RESERVOIR. BLOOD LOSS WAS APPROXIMATELY 600 CC. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COD 712 TOP CIRC RACC CARDIO AUTOTRANSFUSION UNIT, BLOOD COLLECTION DTN SORIN GROUP ITALIA NA 1006150027

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR