BEUDAMED
    FDA Adverse Event Other Summary report: N

    APPARATUS, AUTOTRANFUSION

    MDR report key: 1314008 · Received December 24, 2008

    Report

    Report Number
    1718850-2008-00035
    Event Type
    Other
    Date Received
    December 24, 2008
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K974897
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM. THE MEDWATCH REPORT INDICATED THAT THE BLOOD PROCESSED FROM THE CELL SAVER STARTED TO SEPARATE IN THE IV BLOOD PUMP. TRANSFUSION WAS DISCONTINUED BEFORE REACHING THE PT. THE RISK MGMT MGR WAS CONTACTED AND INDICATED THAT THE PROCESSED BLOOD APPEARED TO BE FINE UNTIL IT WAS PUMPED THROUGH THE IV BLOOD PUMP. AT THAT POINT, THE BLOOD APPEARED TO BE HEMOLYZED WITH CLUMPS. THE RISK MANAGEMENT MGR STATED THAT THERE WAS NO PT INVOLVEMENT. THE BLOOD WAS NOT TRANSFUSED TO THE PT. SORIN GROUP USA REQUESTED TO HAVE THE BRAT DISPOSABLES RETURNED FOR EVAL. THE RISK MANAGEMENT MGR DID NOT KNOW IF THE DISPOSABLE HAD BEEN DISCARDED. TO DATE, THE MGR HAS NOT RESPONDED REGARDING THE DISPOSITION OF THE DISPOSABLES. IF THE PRODUCT IS RETURNED FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPARATUS, AUTOTRANFUSION BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM CAC SORIN GROUP ITALIA NA 0806240041

    Patients

    Seq Age Sex Outcome Treatment
    1