BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK VIP(R)5 VACUUM INFILTRATION PROCESSOR FLOOR 230 V, 50 HZ

    MDR report key: 7050212 · Received November 21, 2017

    Report

    Report Number
    2083544-2017-00002
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    July 3, 2017
    Report Date
    November 21, 2017
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INCIDENT, THE INSTRUMENT WAS UNDER SERVICE CONTRACT WITH (B)(4). THIS SERVICE PROVIDER IS NOT A TRAINED OR AUTHORIZED SERVICE PROVIDER FOR SAKURA INSTRUMENTS IN THE (B)(4). THE SERVICE ENGINEER PERFORMED AN INVESTIGATION OF THE INSTRUMENT ON JULY 14TH, 2017. THE SERVICE REPORT STATES THAT NO ERRORS WERE LOGGED BY THE INSTRUMENT SINCE JUNE 2ND, 2017. THE ONLY FAULTS IDENTIFIED DURING THE SERVICE VISIT ON JULY 14TH, 2017, WERE WAXY DEBRIS IN THE WATER LINE AND SLIGHT LOSS OF PRESSURE FROM THE RETORT LID. BOTH WERE CORRECTED AS WELL AS THE WATER BOTTLES THAT WERE OVERFILLED. ON JULY 20TH, A SAKURA FINETEK (B)(4) SERVICE ENGINEER WAS ON SITE TO PERFORM A COMPLETE PREVENTATIVE MAINTENANCE CHECK AND PRE-CONTRACT ASSESSMENT. DURING THIS VISIT, THE PUMP HEAD WAS REPLACED AS IT WAS WARPED CAUSING POOR PRESSURE TO OCCUR INTERMITTENTLY. THE SERVICE ENGINEER COMMENTED THAT THIS MAY BE DUE TO THE FACT THAT THE DIAPHRAGM USED WAS A NON SAKURA ITEM; BEING THICKER IN SIZE, IT WAS CAUSING STRESS OVER TIME TO THE PUMP HEAD. THE PROBLEM DESCRIPTION FROM THE INVESTIGATION PROTOCOL MENTIONS THAT THE QUALITY OF THE TISSUE PROCESSED ON THE SAKURA VIP 5 WAS SUBSTANDARD (HARD AND BRITTLE). SEVERAL DIFFERENT ROOT CAUSES ARE POSSIBLE FOR PROCESSED TISSUE TO BE HARD AND BRITTLE: ISSUES WITH REAGENT SUCH AS: RESIDUES OF FIXATIVE / WATER REMAINS IN THE TISSUE BEFORE THE CLEARING STEP; EXCESSIVE DEHYDRATION; INCOMPLETE PARAFFIN INFILTRATION; TOO MUCH CLEARING AGENT IN THE PARAFFIN; REAGENT SWAP. TOO MUCH HEAT DURING PROCESSING. INSTRUMENT MALFUNCTION IN VACUUM AND/OR PRESSURE WHICH CAUSED AN INCOMPLETE PROCESSING. FROM AN APPLICATION POINT OF VIEW, LOOKING AT THE REAGENT EXCHANGE REPORTS, IT IS UNLIKELY THAT THE PROBLEM WAS CAUSED BY A REAGENT SWAP OR REAGENT POLLUTION, AS THE REAGENTS WERE CHANGED ON JUNE 27TH, 2017, AND THE FIRST 2 RUNS (JUNE 27TH AND JUNE 29TH) PROCESSED WITHOUT ANY ISSUES. THE PROBLEM OCCURRED IN THE 3RD RUN AFTER THE REFRESHMENT OF REAGENT, MAXIMUM 3*300 CASSETTES (THE REFRESHMENT FREQUENCY CAN BE UP TO 5 RUNS 1500 CASSETTES). NO ABNORMALITIES WERE FOUND IN THE PROTOCOLS OF THE INSTRUMENT. PROTOCOLS ARE, AT LEAST, IN USE FROM AUGUST 2013 AS THIS IS THE ISSUE DATE OF THE DOCUMENT IN WHICH THE PROTOCOLS ARE DESCRIBED. FROM A TECHNICAL POINT OF VIEW IT IS UNLIKELY THAT TOO MUCH HEAT DURING PROCESSING CAUSED THE PROBLEM AS NEITHER (B)(4) AND SAKURA ENGINEERS MENTIONED ANY ISSUES WITH TEMPERATURES. BECAUSE NON SAKURA MAINTENANCE PARTS WERE USED ON THIS SYSTEM, INCORRECT POSITIVE & NEGATIVE PRESSURES WERE GENERATED DURING PROCESS RUNS. THIS HAS BEEN STATED ON BOTH SERVICE REPORTS FROM BOTH (B)(4) AND SAKURA FINETEK (B)(4) SERVICE ENGINEERS. INCORRECT PRESSURES MOST LIKELY AFFECTED THE TISSUE SAMPLES, CAUSED THEM TO BE POORLY PROCESSED DURING ALL PROCESSING STEPS WITHIN A PROCESS RUN. AFTER THE PREVENTIVE MAINTENANCE PERFORMED ON JULY 20TH, 2017, BY A SAKURA FINETEK (B)(4) SERVICE ENGINEER, NO REPORTS OF POORLY PROCESSED TISSUE HAVE BEEN RECEIVED FROM (B)(6) HOSPITAL. BASED ON THE ABOVE SAKURA CONSIDERS THE USE OF NON-SAKURA MAINTENANCE PARTS AND THE RESULTING INTERMITTENT POOR PRESSURE TO BE THE MOST PROBABLE ROOT CAUSE OF THE INCIDENT. AS PART OF THE PREVENTIVE MAINTENANCE PERFORMED ON JULY 20TH, 2017 THE PUMP HEAD WAS REPLACED. THE HEALTH CARE PROVIDER HAS INFORMED SAKURA FINETEK (B)(4) THAT THE CONTRACT WITH THE SERVICE PROVIDER WAS EXPIRING, AND SAKURA FINETEK (B)(4) HAS OFFERED A SERVICE CONTRACT FOR THE IMPACTED INSTRUMENT. IT WAS ADVISED TO REPLACE THE INSTRUMENT AS THE PRODUCT LIFE EXPECTANCY FOR THIS INSTRUMENT IS 7 YEARS.

    Description of Event or Problem · 1

    SAKURA FINETEK USA WAS INFORMED ON NOVEMBER 6TH, 2017, THAT ON MONDAY, (B)(6) 2017, IT CAME TO THE ATTENTION OF USER (HISTOPATHOLOGY DEPARTMENT OF USER FACILITY IN (B)(6)) THAT FOLLOWING THE "AUTOMATED TISSUE PROCESSING" OF PATIENT SAMPLES (MOSTLY BIOPSIES), THE QUALITY OF THE TISSUES PROCESSED ON THE SAKURA VIP 5 (MODULE 4) AUTOMATED TISSUE PROCESSOR APPEARED SUBSTANDARD (BRITTLE AND HARD). THIS WAS IDENTIFIED AT THE "EMBEDDING STAGE" BY THE BMS, WHERE THE TISSUE IS EMBEDDED INTO WAX BLOCKS TO ALLOW SECTIONS TO BE CUT. THIS INDICATED THAT A PROBLEM MAY HAVE OCCURRED DURING TISSUE PROCESSING. MICROTOMY (CUTTING OF THIN SECTIONS FROM THE TISSUE BLOCKS) WAS ATTEMPTED ON A SMALL NUMBER OF THE AFFECTED CASES, AND THE RESULTING SECTIONS WERE STAINED WITH THE HISTOPATHOLOGICAL ROUTINE STAIN. THE MICROTOMY PROCESS WAS VERY DIFFICULT DUE TO THE CONDITION OF THE TISSUE, AND THE RESULTING STAINED SECTIONS SHOWED THAT THE MORPHOLOGY OF THE TISSUE WAS SEVERELY COMPROMISED TO THE EXTENT WHERE A MICROSCOPIC DIAGNOSIS WAS NOT POSSIBLE. A TOTAL OF 81 PATIENTS' TISSUES WERE INVOLVED OR IMPACTED BY THIS EVENT. ACCORDING TO THE HEALTH CARE PROVIDER, RE-BIOPSY WAS REQUIRED. INFORMATION CONCERNING THE NUMBER OF PATIENTS HAS NOT BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828389 TISSUE-TEK VIP(R)5 VACUUM INFILTRATION PROCESSOR FLOOR 230 V, 50 HZ VIP5 IEO SAKURA FINETEK USA, INC. 5217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other