BEUDAMED
    FDA Adverse Event Summary report: N

    BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM

    MDR report key: 5192776 · Received October 30, 2015

    Report

    Report Number
    1718850-2015-00531
    Date Received
    October 30, 2015
    Date of Event
    June 9, 2015
    Report Date
    October 2, 2015
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    CAC
    PMA / PMN Number
    K933625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA, INC. RECEIVED A REPORT THAT THE BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM LOST BLOOD SUPPLY AND WAS UNABLE TO FILTER RED BLOOD CELLS DURING A CASE. THE INCIDENT OCCURRED IN (B)(6). DESPITE MULTIPLE ATTEMPTS TO OBTAIN PATIENT OUTCOME, NO INFORMATION HAS BEEN DISCLOSED TO DATE, WHICH IS WHY A MEDWATCH REPORT WAS FILED. FURTHER ATTEMPTS TO CONTACT THE CUSTOMER RESULTED IN THE RECEIPT OF NEW INFORMATION. THE USER HAS REPORTED THAT THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. WITH THIS NEW INFORMATION, THE COMPLAINT HAS BEEN RECLASSIFIED AS NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP USA, INC. RECEIVED A REPORT THAT THE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM LOST BLOOD SUPPLY AND WAS UNABLE TO FILTER RED BLOOD CELLS DURING A CASE. THE INCIDENT OCCURRED IN (B)(6). DESPITE MULTIPLE ATTEMPTS TO OBTAIN PATIENT OUTCOME, NO INFORMATION HAS BEEN DISCLOSED TO DATE, WHICH IS WHY A MEDWATCH REPORT IS BEING FILED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA, INC. RECEIVED A REPORT THAT THE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM LOST BLOOD SUPPLY AND WAS UNABLE TO FILTER RED BLOOD CELLS DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721441 BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP USA, INC. 007320000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other