BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ME-SC203A TSCDII 110V

    MDR report key: 6832780 · Received August 30, 2017

    Report

    Report Number
    1722028-2017-00366
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    August 6, 2017
    Report Date
    August 30, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    KSB
    PMA / PMN Number
    BK160108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TERUMO BCT PERFORMED A USE TESTING USING AN INTERNAL TSCDII WELDER AND WAS ABLE TO DUPLICATE THE REPORTED CONDITION. DURING THE TESTING, TWO SIMULTANEOUS EVALUATIONS WERE MADE. THE FIRST SIMULTANEOUS EVALUATION WAS AN ISSUE OF THE CARTRIDGE SWITCH. IT WAS NOTED THAT IF THE SWITCH SENSES THAT A WAFER IS IN PLACE, IT WILL PROCEED TO WELD IF THERE IS NO WAFER PRESENT. THIS CAN OCCUR IF THE CARTRIDGE IS MISLOADED. THE 2ND SIMULTANEOUS EVALUATION WAS OBSERVED DURING THE RESISTANCE CHECK OF THE WAFER. AFTER PERFORMING A WELD, THE RESISTANCE OF THE WAFER IS CHANGED AND IS CHECKED TO ENSURE A NEW WAFER HAS BEEN ADVANCED. IF THE RESISTANCE CHECK FAILS, THE SINGLE-USE WAFER CAN BE REUSED WITHOUT THE MACHINE ALARMING. THE TSCDII WELDER WAS RETURNED TO TERUMO BCT LEUVEN FOR EVALUATION. HOWEVER, AN EVALUATION OF THE WAFER CARTRIDGE COULD NOT BE PERFORMED SINCE THE WAFER CARTRIDGE WAS NOT RETURNED FOR EVALUATION. A WELD TESTING, LEAKAGE TESTING, AND TENSILE STRENGTH TEST WERE PERFORMED USING 3 INTERNAL TSCDII WELDERS WITH 2 DIFFERENT TYPE OF TUBING. TEST RESULTS INDICATED THAT THE MULTIPLE WELDS THAT WERE MADE USING A SINGLE-USE WAFER CARTRIDGE SHOWED A DIRECT NEGATIVE IMPACT ON THE QUALITY OF THE WELD. INTERNAL ASEPSIS TEST WAS ALSO PERFORMED FOR 20 ALIQUOTS USING THE SAME WAFER CARTRIDGE. TEST RESULTS INDICATED THAT THE ASEPSIS WAS SECURED. ROOT CAUSE: THE ROOT CAUSE FOR THIS FAILURE WAS IDENTIFIED AS ONE OF THE TWO POSSIBLE ISSUES. 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

    ADDITIONAL 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 IN 18 TSCD II PROCEDURES TO CREATE 25 TRANSFUSABLE BLOOD COMPONENTS, HAD THE POTENTIAL TO LEAD TO MICROBIAL INFECTION AND SEPSIS IN THE 20 PATIENTS TRANSFUSED. 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 BLOODBORNE PATHOGENS DUE TO A TUBING SEAL LEAK IS LOW.

    Additional Manufacturer Narrative · 1

    USING AN IN HOUSE TSCDII WELDER, TERUMO BCT WAS ABLE TO DUPLICATE THEREPORTED ISSUE. DURING THE INVESTIGATION, IT WAS FOUND THAT TWO FAILURES MUST OCCUR SIMULTANEOUSLYFOR THIS ISSUE TO OCCUR. THE FIRST FAILURE IS A FAILURE OF THE CARTRIDGE SWITCH. IF THE SWITCH SENSES THATA WAFER IS IN PLACE, THE DEVICE WILL PROCEED TO WELD IF THERE IS NO WAFER PRESENT. THIS CAN OCCUR IFTHE CARTRIDGE IS MISLOADED. THE SECOND FAILURE IS THE RESISTANCE CHECK OF THE WAFER. AFTER A WELDHAS BEEN MADE, THE RESISTANCE OF THE WAFER IS CHANGED AND IS CHECKED TO ENSURE A NEW WAFER HASBEEN ADVANCED. IF THE RESISTANCE CHECK FAILS, THE SINGLE USE WAFER CAN BE REUSED WITHOUT THEMACHINE ALARMING.NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS DEVICE REGARDING THE REPORTED CONDITION.A REVIEW OF THE LAST YEAR OF SERVICE HISTORY FOR THIS DEVICE INDICATED NO OTHER REPORTS RELATED TO THISISSUE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER STATED THAT WHILE USING THE SEALER DEVICE, THE WAFER CARTRIDGE WAS NOT LOADED CORRECTLY RESULTING IN MULTIPLE WELDS FROM THE SINGLE-USE WAFER. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LAB TECHNICIAN WAS PROCESSING TWO UNITS OF NEONATAL ALIQUOTS WITH THAWED PLASMA PRODUCT. WHILE THE TECHNICIAN WAS PROCESSING THE NEONATAL ALIQUOTS, IT WAS DISCOVERED THAT MULTIPLE WELDS WERE MADE FROM THE SINGLE-USE WAFER. THE CUSTOMER IS ALLEGING A POSSIBLE MICROBIAL CONTAMINATION OF THE PRODUCT. THE CUSTOMER STATED THAT THE SECOND NEONATAL ALIQUOT WAS DISCARDED. PER THE CUSTOMER, THE PLASMA PRODUCTS WERE COLLECTED ON (B)(6) 2017 AND LAB PROCESSING WAS PERFORMED ON (B)(6) 2017. (B)(6). THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF PLASMA PROCESSING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613045 3ME-SC203A TSCDII 110V TSCDII 110V KSB TERUMO BCT 3MESC203A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other