BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 10508567 · Received September 9, 2020

    Report

    Report Number
    1722028-2020-00436
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    June 25, 2020
    Report Date
    September 9, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583103108
    PMA / PMN Number
    K183081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: LOG ANALYSIS IS NOT POSSIBLE DUE TO OPTIA HARD DRIVE DISK REPLACEMENT IN RESPONSE TO FA35 AND PROCEDURES PERFORMED BEFORE JULY 2020 ARE NOT AVAILABLE. PER INTERNAL STERILITY DOCUMENTATION, THE DEVICES TERUMO BCT MANUFACTURES TO COLLECT, SEPARATE, AND STORE BLOOD PRODUCTS ARE TERMINALLY STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF </=10-6. ADDITIONALLY, A STERILITY ASSURANCE SYSTEM HAS BEEN DESIGNED AND EMPLOYED TO ENSURE THIS SAL WILL BE ACHIEVED FOR EVERY LOT OF PRODUCT MANUFACTURED. THE STERILITY ASSURANCE SYSTEM EMPLOYED AT TERUMO BCT ENSURES THE DISPOSABLE DEVICE IS NOT THE SOURCE OF CONTAMINATION. THE THIRD-PARTY CAR-T PROCESSING FACILITY REPORTED THAT THE CULTURE WAS POSITIVE FOR MYCOPLASMA. PER LITERATURE REVIEW MYCOPLASMA REPRESENT A LARGE GROUP OF MICROORGANISMS WHICH ARE ALL CHARACTERIZED BY THEIR LACK OF RIGID CELL WALL, WITH A FLEXIBLE MEMBRANE AND ARE ONE OF THE SMALLEST FREE-LIVING FORMS OF BACTERIA THAT ARE BROADLY DISTRIBUTED IN NATURE. MYCOPLASMA GENERATION TIMES TYPICAL RANGE BETWEEN ONE AND THREE HOURS, BUT ALSO, UP TO NINE HOURS. DUE TO THEIR SMALL SIZE, AND INVISIBLE CHARACTERISTICS, MYCOPLASMAS CAN SPREAD VASTLY AMONG THE CELL CULTURE, THE MAIN SOURCES OF MYCOPLASMA CONTAMINATION VARY FROM CULTURE REAGENTS, LABORATORY STAFF, EQUIPMENT AND CROSS- CONTAMINATION FROM INFECTED CULTURES. THE MOST EFFICIENT WAYS TO PREVENT MYCOPLASMA CONTAMINATION IN CELL CULTURES ARE FOLLOWING A STRICT RULE FOR A GOOD ASEPTIC TECHNIQUE AND CONTROLLING THE SOURCES OF MAKING AEROSOLS WHICH ARE THE MAJOR ROUTE FOR DISTRIBUTION OF MYCOPLASMA CONTAMINATIONS. 1) NIKFARJAM ET AL. "PREVENTION AND DETECTION OF MYCOPLASMA CONTAMINATION IN CELL CULTURE." CELL J. 2012;13(4): 203-212. 2) DREXLER ET AL. "MYCOPLASMA CONTAMINATION OF CELL CULTURES: INCIDENCE, SOURCES, EFFECTS, DETECTION, ELIMINATION, PREVENTION." CYTOTECHNOLOGY 2002: (39): 75-90. ROOT CAUSE : A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SOURCES OF BACTERIAL CONTAMINATION INCLUDES BUT ARE NOT LIMITED TO IMPROPER VENIPUNCTURE TECHNIQUE, NO BLOOD DIVERSION PERFORMED, A COMPROMISED NEEDLE, INLET/RETURN CLAMP WERE OPENED DURING DISPOSABLE REST FAILURE WHILE SYSTEM WAS UNDER VACUUM, MISSING OR DEFECTIVE BACTERIAL STERILE BARRIER, AN ISSUE WITH INLINE CATHETER AND/OR POST-PROCESSING LABORATORY PRACTICES SUCH AS QC SAMPLING OR HANDLING TECHNIQUES. THE CUSTOMER DID NOT REPORT A LEAK IN THE DISPOSABLE SET THAT MAY HAVE POINTED TOWARD AN INSTANCE WHERE BACTERIA COULD BE INTRODUCED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5, H6 & H10 AND CORRECTED INFORMATION IN A.1. INVESTIGATION: THE DISPOSABLE LOT QUERY WAS PERFORMED FOR LOT 1905143230 AND NO SIMILAR REPORTED OCCURRENCES WERE RECEIVED AGAINST THIS LOT TO DATE. DHR: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THERE WAS NOT A TRANSFUSION RECIPIENT INVOLVED BECAUSE THE CUSTOMER DISCARDED THE PRODUCT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TERUMO PROVIDED THE CUSTOMER WITH THE CERTIFICATE OF ANALYSIS AND INFORMED THE CUSTOMER THAT THE COLLECTION SET IS A CLOSED SYSTEM. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION FOR T-CELLS PROCEDURE WAS PERFORMED USING A SPECTRA OPTIA DEVICE. THE CUSTOMER REPORTED THAT THE COLLECTED PRODUCT WAS FOUND TO BE CONTAMINATED WITH MYCOPLASMA. PER THE CUSTOMER, THERE WERE NO ISSUES DURING THE RUN, SUCH AS VENOUS ACCESS OR DISCONNECTION OF THE INLET OR OUTLET LINES. THE CUSTOMER THEN REPORTED THAT THIRD PARTY LAB FINDINGS SUGGEST THE CONTAMINATION IS FROM THE COLLECTION SIDE. THERE WERE NO EFFECTS ON THE PATIENT. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975512 SPECTRA OPTIA SPECTRA OPTIA IDL SET GKT TERUMO BCT 10310 1905143230 05020583103108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other