BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7235865 · Received February 2, 2018

    Report

    Report Number
    2083544-2018-00002
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    September 28, 2017
    Report Date
    January 3, 2018
    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

    INFORMATION RECEIVED FROM HEALTH CARE PROVIDER: "ALL PATIENTS ARE RETURNING TO SEE THEIR CONSULTANTS IN (B)(6) 2018. EXACT NUMBER OF REPEAT SAMPLES UNKNOWN AS IT RELATES TO SKIN SAMPLES. ALL PATIENTS TO BE OFFERED EXTENDED MONITORING." ALSO THE FOLLOWING ACTION PLAN WAS PROVIDED BY THE HEALTH CARE PROVIDER: ACTION NUMBER, RESPONSIBLE AND TARGET DATE: PURCHASE AND INSTALL SHELVING JW/DR (B)(4) 2017; PRODUCE HOUSEKEEPING ASSISTANT TRAINING GUIDE LTA (B)(4) 2018; INTRODUCE SEGREGATION/SIGNAGE IN PROCESSING ROOM CHEMICAL STORES JW/DR (B)(4) 2017; REQUEST REAGENT COLOUR CODING FROM SUPPLIER JW (B)(4) 2017; INSTRUCT STAFF IN VENTILATING ROOM IF WARM MJ (B)(4) 2017; HIGHLIGHT STAFFING PRESSURES/RESOURCE ISSUES TO EXECUTIVE TEAM VIA DISTRIBUTION OF THIS REPORT JW (B)(4) 2017; ADVISE STAFF REGARDING PLANNING AND WORK WITH STAFF VIA CUT-UP MEETING IN WHAT IS REQUIRED TO ACHIEVE THIS OG (B)(4) 2018; ADD TO THE CURRENT TISSUE PROCESSING TRAINING MODULE SCENARIOS AND INFORMATION BASED ON THE IMPACT OF INCORRECT REAGENTS ON TISSUES LTA (B)(4) 2018; INTRODUCE A SECOND CHECK ON REAGENTS AND UPDATE SOPS ACCORDINGLY OG/DR/NV (B)(4) 2018. ALTHOUGH THE HEALTH CARE PROVIDER DID NOT INFORM SAKURA OF THIS ADVERSE INCIDENT AND THE IMPACT TO PATIENT TISSUE, A SERVICE REQUEST WAS MADE TO SAKURA FINETEK (B)(4). THE SERVICE VISIT WAS PERFORMED ON (B)(4) 2017, TO ADDRESS THE ACID ALCOHOL CONTAMINATION ISSUE DUE TO THE REAGENTS MIX UP. THE PROCESSOR WAS STRIPPED AND THE ROTARY AND GATE VALVE #25 AND SEVERAL O RINGS WERE REPLACED. COMPONENTS SHOWING WEAR AND TEAR, INTERNAL BOTTLE CAP, CRACKED FITTINGS, WERE ALSO REPLACED. THE PROCESSOR WAS TESTED AT THE END OF SERVICE USING A TEST RUN AND FOUND TO BE ACCEPTABLE. THE VIP 5 MODEL IS AN OLDER VACUUM INFILTRATION PROCESSOR THAT IS CURRENTLY NO LONGER BEING MARKETED BY SAKURA. IT DOES NOT HAVE AN ELECTRONIC LOG OF ERRORS DURING PROCESSING RUNS AND AS SUCH SAKURA FINETEK IS UNABLE TO INVESTIGATE THIS INCIDENT FROM A TECHNICAL POINT OF VIEW. HOWEVER, THE HEALTH CARE PROVIDER REQUESTED SAKURA TO COMPLETE THE INVESTIGATION PROTOCOL. SAKURA HAS NO CONTROL OVER USER RELATED ERRORS AND AS SUCH CANNOT IMPLEMENT CORRECTIVE OR PREVENTIVE ACTIONS. [(B)(4).PDF].

    Description of Event or Problem · 1

    SAKURA FINETEK EUROPE (B)(4) WAS INFORMED BY (B)(6) ON JANUARY 3RD, 2018, THAT ON (B)(6) 2017, A TECHNICIAN FROM THE HEALTH CARE PROVIDER PLACED INCORRECT REAGENTS IN STATION 2 OF THE PROCESSOR. THIS ERROR RESULTED IN COMPROMISED MORPHOLOGY OF PATIENT TISSUES. SEVENTY-SIX (76) OF 79 PATIENT SAMPLES WERE AFFECTED AND THE PATHOLOGIST WAS UNABLE TO MAKE DIAGNOSIS. THE HEALTH CARE PROVIDER STATED THAT THE INCIDENT WAS CAUSED BY A REAGENT MIX UP BY A TECHNICIAN: 1% ACID ALCOHOL WAS PLACED IN STATION 2 INSTEAD OF 99% IMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80064 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