BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK VIP 6

    MDR report key: 3262821 · Received February 14, 2013

    Report

    Report Number
    2083544-2013-00001
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR MISTAKENLY AND ERRONEOUSLY CAUSED THIS INCIDENT. THIS INCIDENT WAS DUE TO THE MODIFICATION OF THE PROGRAM POST START OF RUN/DURING TISSUE PROCESSING. THE MID RUN MODIFICATION CAUSED THE SOFTWARE OF THE INSTRUMENT OT NOT RECOGNIZE THE FIRST SOLUTION BOTTLE. THIS IS WHY THE SOLUTION WAS PUMPED IN THE SECOND BOTTLE INSTEAD OF THE FIRST BOTTLE WHERE THE SOLUTION ORIGINATED FROM. THE OPERATING MANUAL CLEARLY STATES: "THE EDIT MENU PROVIDES ACCESS TO SEVERAL OPTIONS THAT ALLOW THE USER TO CONFIGURE THE SYSTEM OPERATING DEFINITIONS, SETTINGS, AND PROGRAMS THAT SHOULD BE ESTABLISHED PRIOR TO SYSTEM USE". WHEN CONFIRMING THE EVENT ON A UNIT A SAKURA FINETEK (B)(4), IT WAS FOUND THAT THE EDIT MENU CANNOT BE USED TO ALTER RUNNING PROGRAMS, HOWEVER, BY PAUSING THE PROGRAM, THE USER CAN ACCESS THE EDIT MODE AND ALTER THE RUNNING PROGRAM. IT IS CONSIDERED EXTREMELY UNUSUAL FOR THE OPERATOR TO PAUSE AND MODIFY THE RUNNING PROGRAM. FURTHERMORE, ALTERING THE CONDITIONS OF THE PROGRAM AFTER STARTING THE RUN IS CONSIDERED AS UNINTENDED USE OF THE DEVICE. HEALTH CARE FACILITY IPG IS INFORMED NOT TO CHANGE PROGRAMS AFTER STARTING THE PROCESS. EVEN THOUGH THIS UNUSUAL AND ERRONEOUS PROCESS HAS NEVER BEEN UTILIZED BY ANY OTHER LAB, AND THIS IS THE FIRST AND ONLY INCIDENT EVER REPORTED TO SAKURA. SAKURA WILL BE NOTIFYING ALL VIP6 USERS TO NOT PAUSE AND EDIT RUNNING PROGRAM. IN ADDITION, AS A PREVENTIVE MEASURE, A SOFTWARE UPDATE WILL BE PROVIDED TO ALL CUSTOMERS. THE UPDATE WILL PREVENT USERS FROM MAKING ANY CHANGES TO THE PROCESSING PARAMETERS DURING TISSUE PROCESSING.

    Description of Event or Problem · 1

    AFTER STARTING THE PROGRAM ON SATURDAY FOR AUTOMATED PROCESSING OF TISSUE, THE CUSTOMER MODIFIED THE PROGRAM BY CHANGING THE TIME FOR STATION #1 FROM 40 MINUTES TO 0 MINUTES. ALTHOUGH POSSIBLE IN THE SOFTWARE, THE MODIFICATION OF THE PROGRAM DURING THE ACTUAL RUN IS CONSIDERED HIGHLY UNUSUAL. AS A RESULT, THE NEXT DAY THE MACHINE PUMPED THE REAGENT PRESENT IN THE RETORT (TISSUE CHAMBER) INTO THE SECOND SOLUTION BOTTLES. THE MACHINE CONTINUED PROCESSING WITH THE CONTAMINATED SOLUTIONS. THIS RESULTED IN TISSUE SPECIMENS THAT COULD NOT BE DIAGNOSED. SOME OF THE SPECIMENS COULD NOT BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66351 TISSUE-TEK VIP 6 TISSUE PROCESSOR IEO SAKURA FINETEK USA, INC. 6032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other