BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COD.712 TOP CIRC.RACC.CARDIO

    MDR report key: 1931924 · Received December 13, 2010

    Report

    Report Number
    1718850-2010-00177
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 18, 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. THIS IS A COMPONENT OF THE BLOOD COLLECTION SET. THE INCIDENT OCCURRED AT CLINIQUE CLEMENT DREVON IN (B)(4). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE ANESTHESIOLOGIST REPORTED THAT, DURING THE PROCEDURE, THE CARDIOTOMY FILTER DETACHED FROM THE RESERVOIR LID. SORIN GROUP (B)(4) REQUESTED THE RESERVOIR BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FORWARDED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PATIENT INJURY. THE HOSPITAL REPORTED THIS INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE ANESTHESIOLOGIST REPORTED THAT, DURING THE PROCEDURE, THE CARDIOTOMY FILTER DETACHED FROM THE RESERVOIR LID. APPROXIMATELY 500 ML OF BLOOD WAS LOST. IT WAS REPORTED THAT THE RESERVOIR WAS NOT BROKEN WHEN THE PACKAGE WAS OPENED. THE PACKAGE WAS NOT DAMAGED. 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 1005120083

    Patients

    Seq Age Sex Outcome Treatment
    1