BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ME-SC203A TSCDII 110V

    MDR report key: 7154098 · Received December 29, 2017

    Report

    Report Number
    1722028-2017-00521
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 29, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    KSB
    PMA / PMN Number
    BK160108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ONE YEAR OF SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE WITH NO ISSUES RELATED TO THE REPORTED CONDITION IDENTIFIED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: FURTHER EVALUATION OF THIS EVENT HAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR IS THERE A LIKELY POTENTIAL FOR DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT BASED ON ADDITIONAL INVESTIGATIONAL INFORMATION. PER TERUMO BCT'S INTERNAL RISK DOCUMENTATION, THE REPORTED INCIDENT WHERE THE SAME CUT/WELD WAFER WAS USED TO CREATE 10 WELDS HAD THE POTENTIAL TO LEAD TO MICROBIAL INFECTION IF USED FOR TRANSFUSABLE PRODUCTS. THE HEALTH RISK IS MOST LIKELY LOW DUE TO THE HEAT GENERATED BY THE WAFER WHEN THE TSCD II DEVICE WELDS THE PVC TUBING TOGETHER, KILLING ANY MICROBES PRESENT. AS LONG AS THE USED WAFER REACHED A TEMPERATURE OF 300 ± 50 C FOR EVERY PROCEDURE AS MONITORED BY THE SYSTEM, THE PROBABILITY OF A VIABLE MICROBE CONTAMINATING THE RESULTANT BLOOD COMPONENT IS LOW AND THE RISK OF OPERATOR-EXPOSURE TO BLOOD BORNE PATHOGENS DUE TO A TUBING SEAL LEAK IS LOW. THE DEVICE SERIAL NUMBER HISTORY REPORT INDICATES NO FURTHER RELATED ISSUES HAVE BEEN REPORTED FOR THIS DEVICE. ROOT CAUSE: THE ROOT CAUSE FOR WAFERS BURNING THROUGH THE TUBING WAS A SINGLE WAFER HAD BEEN USED MULTIPLE TIMES. IF THE DEVICE CAN MAKE MULTIPLE WELDS WITH 1 WAFER 2 FAULTS HAVE TO OCCUR: THE USED WAFER IS STILL WITHIN SPEC: TEMPERATURE/RESISTANCE STILL IN RANGE; THE FEEDING MECHANISM ISN¿T WORKING PROPERLY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER STATED THAT THEY PERFORMED 10 SEALS ON THE TUBING LINE, HOWEVER, BLACK 'BURN' MARKS WERE OBSERVED ON THE 3RD SEAL AND WAS UNABLE TO COMPLETE THE 7TH SEAL DUE TO ERROR ALARMS. THE TSCDII DEVICE WAS RETURNED TO TERUMO BCT FOR REPAIR AND INVESTIGATION. A SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND NOTICED THAT THE WAFER CARTRIDGE WAS IN THE JAMMED POSITION. THE SERVICE TECHNICIAN CAREFULLY PRYED THE CARTRIDGE OUT AND WAS UNABLE TO DUPLICATE THE REPORTED CONDITION. SIMULATED USE TESTING WAS PERFORMED USING THE TSCDII DEVICE. WHILE PROVIDING MULTIPLE SAMPLES OF BURNED WELDS AND WAFERS, IT WAS CONFIRMED THAT THE SAME WAFER WAS BEING USED OVER AND OVER AGAIN CAUSING BURNING OF WELD AND WAFER. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT ONE SAMPLE WAFER HAD EXTREME CORROSION WHILE SETTING IN THE CARTRIDGE. IT WOULD HAVE BEEN THE FIRST IN THE CARTRIDGE AT THE OPEN END. THIS MAY HAVE BEEN A PROBLEM AND CAUSED THE BLOCK OF WAFERS TO STICK AND NOT ADVANCE WHILE HOLDING DOWN THE WAFER CARTRIDGE SWITCH. THE SERVICE TECHNICIAN MADE MANY WELDS BEFORE THE 30 TEST WELDS NEEDED TO PERFORM A WELD INTEGRITY TEST. NO ERRORS OCCURRED. THE CARTRIDGE WAS CHANGED AND ADDITIONAL 4 WELDS. THE TSCDII WAS RETURNED TO THE CUSTOMER AND THE CUSTOMER INSTALLED THE TSCDII DEVICE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING CUSTOMER FOLLOW-UP, THE CUSTOMER STATED THAT THE REPORTED EVENT OCCURED DURING TRAINING WITH HEALTHY DONOR CELLS. THERE WAS NO PATIENT OR DONOR INVOLVED AND THERE WAS NO INTENT FOR THE CREATED PRODUCT TO BE TRANSFUSED TO A PATIENT OR DONOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE SEALING THE TUBING LINE USING THE TRIMA SEALER (TSCDII)DEVICE, THEY RECEIVED MULTIPLE ERROR ALARMS INCLUDING 'DEFECTIVE WAFER, PRESS RESET' ALARM AND OBSERVED BLACK 'BURN' MARKS ON THE TUBING LINE. THE TRIMA DEVICE WAS RETURNED FOR REPAIR AND EVALUATION. UPON EVALUATION OF THE DEVICE, THE TERUMO BCT SERVICE TECHNICIAN DISCOVERED THAT MULTIPLE WELDS WERE MADE FROM A SINGLE-USE WAFER. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935039 3ME-SC203A TSCDII 110V TSCDII 110V KSB TERUMO BCT 3MESC203A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other