BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPACT WS125C

    MDR report key: 1695917 · Received May 17, 2010

    Report

    Report Number
    1718850-2010-00101
    Event Type
    Other
    Date Received
    May 17, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 27, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K982650
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE COMPACT WASH SET. THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE TECHNICIAN REPORTED THAT AT THE END OF PROCESSING AUTOLOGOUS BLOOD AND DURING THE EMPTY MODE, AN ERROR MESSAGE DISPLAYED ON THE COMPACT MACHINE. AS THE TECHNICIAN POWER CYCLED THE MACHINE, A POPPING SOUND WAS HEARD. THE TUBING LINE ON THE OUTLET OF THE RESERVOIR SEPARATED, SPRAYING BLOOD IN THE ROOM, ON THE TECHNICIAN AND IN THE STERILE FIELD. THE PROCESSING SET WAS INADVERTENTLY DISCARDED BY THE HOSPITAL. THE CAUSE OF THE INCIDENT CAN NOT BE DETERMINED WITHOUT THE PHYSICAL PRODUCT FOR EVALUATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THERE WAS PERSONNEL BLOOD EXPOSURE DURING THIS INCIDENT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THE EXPOSURE.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THAT AT THE END OF PROCESSING AUTOLOGOUS BLOOD AND DURING THE EMPTY MODE, AN ERROR MESSAGE DISPLAYED ON THE COMPACT MACHINE. AS THE TECHNICIAN POWER CYCLED THE MACHINE, A POPPING SOUND WAS HEARD. THE TUBING LINE ON THE OUTLET OF THE RESERVOIR SEPARATED, SPRAYING BLOOD IN THE ROOM, ON THE TECHNICIAN AND IN THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT WS125C APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP ITALIA NA 1001200103

    Patients

    Seq Age Sex Outcome Treatment
    1