BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM

    MDR report key: 4208972 · Received October 16, 2014

    Report

    Report Number
    1718850-2014-00384
    Event Type
    Other
    Date Received
    October 16, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 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 REPORT THAT THE BRAT2 AUTOLOGOUS BLOOD SALVAGE SYSTEM SHUT DOWN BY ITSELF DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. WHILE ONE SITE, THE SERVICE REPRESENTATIVE WAS ABLE TO REPRODUCE THE ISSUE AND FOUND THAT IT WAS CAUSED BY A PROBLEM WITH THE PROCESS INTERFACE BOARD. THE BOARD WAS REPLACED AND SUBSEQUENT TESTING CONFIRMED THAT THE UNIT WAS FUNCTIONING PROPERLY. IT WAS LATER REPORTED THAT THIS UNIT HAS BEEN TAKEN OUT OF SERVICE AND IS NO LONGER IN USE BY THE FACILITY. THE REPLACED CIRCUIT BOARD WAS RETURNED TO SORIN GROUP USA FOR EVALUATION AND SIMULATED USE TESTING CONFIRMED THE REPORTED ISSUE. THE RETURNED CIRCUIT BOARD WILL BE SCRAPPED AS A PRECAUTION. THE BRAT2 MACHINE IS NO LONGER BEING MANUFACTURED AND NO TREND HAS BEEN IDENTIFIED, THEREFORE NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE BRAT2 AUTOLOGOUS BLOOD SALVAGE SYSTEM SHUT DOWN BY ITSELF DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658084 BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR