BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAT 2 SYSTEM

    MDR report key: 2240592 · Received August 26, 2011

    Report

    Report Number
    1718850-2011-00096
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    CAC
    PMA / PMN Number
    K991986
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) WAS NOTIFIED THAT THE CUSTOMER HAD EXPERIENCED REPEATED VACUUM REGULATION ERRORS WITH THEIR BRAT 2 SYSTEMS. ON EVAL AT THE CUSTOMER SITE, A SORIN GROUP (B)(4) SERVICE REP FOUND THAT THE HYDROPHOBIC FILTER OF THE BRAT 2 VACUUM SYSTEMS WERE CLOGGED. THE FILTERS WERE CHANGED OUT AND THE DEVICES RETURNED TO SERVICE. WITHIN WEEKS OF REPLACEMENT, THE VACUUM REGULATION ERROR WERE REPEATED AND WERE AGAIN TRACED TO CLOGGED HYDROPHOBIC FILTERS. THE FILTERS WERE CLOGGING PREMATURELY. THE HOSP'S DIRECTOR OF BIOMEDICAL ENGINEERING NOTIFIED SORIN GROUP (B)(4) THAT THE REPEATED VACUUM REGULATION ERRORS RESULTING FROM PREMATURELY FAILING HYDROPHOBIC FILTERS WAS A PT SAFETY ISSUE. NO ADVERSE EFFECTS ON ANY PTS WERE REPORTED. SORIN GROUP (B)(4) NOTIFIED THE SUPPLIER OF THE HYDROPHOBIC FILTER OF THE ISSUES REPORTED WITH THEIR COMPONENT AND RETURNED SAMPLES TO THEM FOR EVAL. THE SUPPLIER NOTIFIED SORIN GROUP (B)(4) THAT THEIR INVESTIGATION FOUND THAT THE LAYERED MATERIAL OF THE FILTER MEDIA WAS NOT ASSEMBLED CORRECTLY. THE INCORRECT ORIENTATION OF THE FILTER MEDIA LEAD TO PREMATURE CLOGGING, AS REPORTED BY THE CUSTOMER. IT SHOULD BE NOTED THAT THE FILTER STILL FUNCTIONED PROPERLY. HOWEVER, THE DURATION OF USE WAS SHORTER THAN NORMALLY EXPERIENCED BY THE USER. THE SUPPLIER STATED THAT THE FILTERS IN QUESTION WERE MFG AT A SITE NO LONGER IN OPERATION. SINCE THE MFG PROCESS HAS BEEN MOVED, PRODUCTION MACHINERY AND PROCESSES WERE VALIDATED PRIOR TO INITIATING PRODUCTION AT THE NEW SITE. THE SUPPLIER FURTHER STATED THAT PROCESS IMPROVEMENTS WERE IMPLEMENTED BEFORE FILTERS WERE PRODUCED AT THIS NEW SITE. THE BRAT 2 SYSTEM IFU STATES THAT, "THE BRAT 2 VACUUM SYSTEM OPTION IS AN INTERNAL SOURCE OF VACUUM FOR ASPIRATION. IT IS A SUBSTITUTE FOR HOSPITAL VACUUM" WHEN USED FOR AUTOLOGOUS BLOOD SALVAGE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF REPEATED VACUUM REGULATION ISSUES WITH THE BRAT 2 AUTOTRANSFUSION SYSTEM. THE DIRECTOR OF BIOMEDICAL ENGINEERING AT THE HOSPITAL STATED THAT THE PERSISTENCE OF VACUUM REGULATION ERRORS ON THE MACHINE PRESENTED A PT SAFETY ISSUE. NO REPORTS OF ADVERSE EFFECTS ON ANY PTS WERE CITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAT 2 SYSTEM APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP USA, INC. 007320200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1