BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLEX 300I V2.5 DISPOSABLE SET

    MDR report key: 715594 · Received August 8, 2005

    Report

    Report Number
    6000001-2005-03244
    Event Type
    Malfunction
    Date Received
    August 8, 2005
    Date of Event
    July 19, 2005
    Report Date
    August 8, 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 NOTICE THAT STATED, "HOTLINE CALL, 1ST CALL: BIG CLOT VISIBLE IN PRIMARY CHAMBER DURING ROSETTING, PRECEDING WASH PROCEDURES DID NOT SHOW CONSPICUITIES. 2ND CALL: REPEATED EC79 AT START RELEASE AGENT WASH. DONOR WILL UNDERGO A BONE MARROW EXTRACTION. NO DONOR/TECHNICIAN ISSUES. NO SAMPLE AVAILABLE FOR EVALUATION. PROBLEM NOTED DURING USE. PT DID NOT RECEIVE THE PRODUCT. PT DID NOT HAVE ENOUGH STEM CELL CELLS FOR ENGRAFTMENT. CLINICIANS DECIDED TO PROCEED WITH DONORS BONE MARROW FOR TRANSPLANTATION WITHOUT CD34 SELECTION. PRODUCT INFORMATION = MOB. APHERESIS PRODUCT, ONE FRACTION STORED OVER NIGHT, POOLED WITH FRESH PRODUCT. ACTION TAKEN: 1ST CALL: NO PULMOZYME AVAILABLE AT SITE, NO POSSIBILITY TO DISSOLVE CLOT. 2ND CALL: CUSTOMER QUIT EC79 SEVERAL TIMES BY PRESSING OK, ERROR CAME UP AGAIN AND AGAIN. RIGHT BEFORE HE ATTACHED NEW BUFFER BAG DUE TO EC95 (UNUSUALLY HIGH AMOUNT OF BUFFER HAD BEEN USED FOR PROCEDURE). 1 SMALL CLOT VISIBLE IN SPINNER. WASTE BAGS NOT COMPLETELY FILLED, PLACED ON TABLE BESIDE INSTRUMENT, SEEMS TO BE OK. "CHECKED OUTFLOW OF SPINNER BY ATTACHING NEW WASTE BAG, STARTING WASH AGAIN AND LIFTING WASH BAG, RECOGNIZED FLUID COMING OUT OF SPINNER, NOT COMPLETELY CLOGGED. WASHING BAG 2 WEIGHT ABOUT 460ML. DISCUSSED OPTIONS FOR RELEASE AGENT WASH AND VOLUME REDUCTION, BY CENTRIFUGATION STEPS OR BY SYSTEM OPERATION TEST MODE. RESTART OF DEVICE, HARDWARE TEST PASSED, SELECT SYSTEM OPERATION TEST. INSTRUCTEDS FOR VOLUME REDUCTION USING SPINNER MODULE (C5,7,20 OPEN/M3 POS, M4 POS DIRECTION, BOTH PUMPS STARTING WITH 20 INCREASING SPEED TO 40/ SPINNER POS DIRECTION +500). THEN, TRANSFERRED BUFFER TO WB2 DILUTION (C5,7,12,14,16 OPEN/M3 POS, M2 NEG DIRECTION, BOTH PUMPS STARTING WITH 20 INCREASING SPEED TO 40/ SPINNER POST DIRECTION +500) AND SUBSEQUENT VOLUME REDUCTION. REPEATED WASHING TWICE. DURING SECOND VOLUME REDUCTION STEP, CONTROLLED OUTFLOW RATE SEVERAL TIMES=10MIL/MIN ONLY. END VOLUME ADJUSTED TO 100ML. POSITIVE FRACTION WAS CRYOPRESERVED. ON 7/2005: RESULTS: CD34+-RECOVERY: 2%. CD34-CELL DOSE FOR PATIENT: 0.1 X 10E6/KG (TOO LOW FOR CLINICAL PROTOCOL)." ADDITIONAL INFORMATION AND DATA (CORRECT LOT NUMBER) HAS BEEN REQUESTED.

    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 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR