BEUDAMED
    FDA Adverse Event Other Summary report: N

    COD.712 TOP CIRC.RACC.CARDIO

    MDR report key: 2392356 · Received December 15, 2011

    Report

    Report Number
    1718850-2011-00252
    Event Type
    Other
    Date Received
    December 15, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 14, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K992599
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THIS CARDIOTOMY RESERVOIR. ALTHOUGH CAT # 0405 IS NOT MARKETED IN THE U.S, IT IS EQUIVALENT TO US CAT # 04116 WHICH WAS CLEARED UNDER 510(K)# K992599. 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 AUTO-TRANSFUSION RESERVOIR. THE DETACHMENT OF THE FILTER ALLOWED DEBRIS TO PASS INTO THE AUTO-TRANSFUSION MACHINE CAUSING A BLOCKAGE AND PRESSURE INCREASE. THE INCREASED PRESSURE CAUSED THE WASH BOWL TO FRACTURE, RESULTING IN AN INABILITY TO RE-INFUSE THE SALVAGED BLOOD. THERE AS NO REPORT OF PT INJURY. IT WAS LATER REPORTED THAT THE PT HAD RARE ANTIBODIES SO BANK BLOOD WAS NOT AVAILABLE AND SPECIAL PROCEDURES HAD TO IMPLEMENTED TO PROVIDE THE NECESSARY BLOOD PRODUCTS. THE DEVICE WAS DISCARDED BY THE USER AND IS, THEREFORE, NOT AVAILABLE FOR EVAL. WITHOUT THE RESERVOIR FOR EVAL, THE ROOT CAUSE FOR THE ISSUE CANNOT BE DETERMINED. THERE WAS NO REPORT OF PT INJURY AS A RESULT OF THIS EVENT. THE ELECTA AUTOTRANSFUSION MACHINE INSTRUCTIONS FOR USE STATE, "AN ADEQUATE QUANTITY OF SALVAGED, VIABLE, WASHED, PACKED RED BLOOD CELLS CANNOT ALWAYS BE PREDICTED OR DEPENDED UPON IN A BLOOD SALVAGE PROCEDURE. PHYSICIAN SHOULD BE PREPARED TO INSTITUTE APPROPRIATE ADD'L THERAPY IF NECESSARY."

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FILTER BECAME DETACHED FROM THE AUTO-TRANSFUSION RESERVOIR. THE DETACHMENT OF THE FILTER ALLOWED DEBRIS TO PASS INTO THE AUTO-TRANSFUSION MACHINE CAUSING A BLOCKAGE AND PRESSURE INCREASE. THE INCREASED PRESSURE CAUSED THE WASH BOWL TO FRACTURE, RESULTING IN AN INABILITY TO RE-INFUSE THE SALVAGED BLOOD. THERE WAS NO REPORT OF PT 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 1106220055

    Patients

    Seq Age Sex Outcome Treatment
    1