BEUDAMED
    FDA Adverse Event Death Summary report: N

    FMC/LAS VEGAS NV1

    MDR report key: 820147 · Received February 21, 2007

    Report

    Report Number
    1718850-2007-00004
    Event Type
    Death
    Date Received
    February 21, 2007
    Date of Event
    January 19, 2007
    Report Date
    January 30, 2007
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTN
    PMA / PMN Number
    k990239
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESERVOIR WAS AUTOPSIED BY THE SURGEON POST SURGERY AND NOT RETURNED. NO CLOTS WERE REPORTED IN THE CARDIOTOMY SUCTION CARTRIDGE OF THE VENOUS RESERVOIR. WITHOUT THE PRODUCT, NO EVALUATION COULD BE CONDUCTED BY SORIN GROUP USA. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE RESERVOIR WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PT WAS ON BYPASS BEING COOLED IN PREPARATION FOR CIRCULATORY ARREST TO REPLACE A LARGE DISEASED SECTION OF THE AORTA DUE TO A SEVERE AORTIC ANEURYSM WHEN BLOOD LOSS TO THE SURGICAL FIELD SUDDENLY INCREASED. CARDIOTOMY AND VENT SUCTION RATES WERE INCREASED TO SALVAGE THIS BLOOD. THE VOLUME IN THE VENOUS RESERVOIR DROPPED AND THE VOLUME IN THE CARDIOTOMY FILTER CARTRIDGE AND CELL SAVER INCREASED. THE VENOUS LINE TO THE RESERVOIR APPEARED TO BE AIR LOCKED. VACUUM WAS INCREASED TO THE VENOUS RESERVOIR, BUT THIS DID NOT REMEDY THE CONDITION. IT WAS ALSO NOTED THAT THE CARDIOTOMY FILTER CARTRIDGE HAD PRESSURIZED. AIR HAD FILLED THE PRIME BAGS CONNECTED TO THE CARDIOTOMY FILTER AND WHEN A CAP WAS REMOVED FROM A CARTRIDGE PORT, AIR AND BLOOD READILY ESCAPED. AIR ENTERED THE ARTERIAL LINE, BUT DID NOT PASS THE ARTERIAL FILTER. THE PT WAS THEN PLACED ON CIRCULATORY ARREST AND PUMP AND BYPASS CIRCUIT WERE REPLACED TO COMPLETE THE PROCEDURE. POST SURGERY, THE PT LOST 5 LITERS OF BLOOD, AND EXPIRED WHEN LIFE SUPPORT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMC/LAS VEGAS NV1 CUSTOM PERFUSION PACK DTN SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death