BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM

    MDR report key: 3902397 · Received June 24, 2014

    Report

    Report Number
    1718850-2014-00190
    Event Type
    Other
    Date Received
    June 24, 2014
    Date of Event
    January 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    CAC
    PMA / PMN Number
    K933625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A USER MEDWATCH REPORT INDICATING THE CELL SAVER MACHINE STOPPED WORKING. THE MEDWATCH REPORT STATED TYPE AND CROSS-MATCHED BLOOD HAD TO BE SUBSTITUTED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. MEDWATCH USER REPORT NUMBER: 3600510000-2014-8015.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A USER MEDWATCH REPORT INDICATING THE CELL SAVER MACHINE STOPPED WORKING. THE MEDWATCH REPORT STATED TYPED AND CROSS-MATCHED BLOOD HAD TO BE SUBSTITUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368867 BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR