BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLEX 300I V2.5 DISPOSABLE SET

    MDR report key: 694881 · Received September 28, 2005

    Report

    Report Number
    6000001-2005-04720
    Event Type
    Malfunction
    Date Received
    September 28, 2005
    Date of Event
    August 30, 2005
    Report Date
    September 28, 2005
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTIFICATION OF EVENT AT FACILITY IN 2005 THAT STATED, "REPEATED ERROR CODES DURING TRANSFER OF POSITIVE FRACTION TO WASH BAG 2 AFTER RELEASE INCUBATION. CD34-RECOVERY WAS POOR AND DONOR HAS TO BE REMOBILIZED AND RECOLLECTED NEXT WEEK TO PERFORM AN ADDITIONAL CD34-SELECTION." INFO RECEIVED IN 2005 STATED, "THERE IS NO SAMPLE AVAILABLE FOR EVALUATION. PROBLEM WAS NOTED DURING USE. PT DID NOT RECEIVE THE PRODUCT AS POSITIVE FRACTION WAS CRYOPRESERVED. THE CD34 RECOVERY WAS 26.1%. THERE WAS NO STERILITY RISK AND/OR MED INTERVENTION REQUIRED. CD34 COUNT IN POSITIVE FRACTION TOO LOW FOR TRANSPLANTATION, AN ADDITIONAL POSITIVE SELECTION WILL BE PERFORMED. TOTAL CELL DOSE INFUSED CD34=10^6/KG X 1.84 WHICH WAS CRYOPRESERVED, THE PT DID NOT UNDERGO THERAPY AND/OR TRANSPLANTATION YET. THE RECOLLECTION/REMOBILIZING PLANNED FOR 6 DAYS LATER WAS POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLEX 300I V2.5 DISPOSABLE SET ISOLEX DISPOSABLE SET MZK BAXTER HEALTHCARE CORP. NA H04E10046

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR