BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR

    MDR report key: 3031942 · Received March 27, 2013

    Report

    Report Number
    1718850-2013-00046
    Event Type
    Other
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K992599
    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 THE DIDECO ATS AUTOTRANSFUSION RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FILTER BECAME DETACHED FROM THE AUTOTRANSFUSION CARDIOTOMY RESERVOIR AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. 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 THAT THE FILTER BECAME DETACHED FROM THE AUTOTRANSFUSION CARDIOTOMY RESERVOIR AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125622 DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR AUTOTRANSFUSION RESERVOIR DTN SORIN GROUP ITALIA NA 1211080184

    Patients

    Seq Age Sex Outcome Treatment
    1