BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 20401109 · Received October 8, 2024

    Report

    Report Number
    1722028-2024-00434
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 11, 2023
    Report Date
    October 8, 2024
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583102200
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. CITATION: JO, T., ARAI, Y., KITAWAKI, T., NISHIKORI, M., MIZUMOTO, C., KANDA, J., YAMASHITA, K., NAGAO, M., & TAKAORI-KONDO, A. (2023). RISK ANALYSIS OF FLUCTUATING HYPERCALCEMIA AFTER LEUKAPHERESIS IN CELLULAR THERAPY. SCIENTIFIC REPORTS, 13(1). HTTPS://DOI.ORG/10.1038/S41598-023-42159-1 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 H.6 AND H.11. LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. CITATION: JO, T., ARAI, Y., KITAWAKI, T., NISHIKORI, M., MIZUMOTO, C., KANDA, J., YAMASHITA, K., NAGAO, M., & TAKAORI-KONDO, A. (2023). RISK ANALYSIS OF FLUCTUATING HYPERCALCEMIA AFTER LEUKAPHERESIS IN CELLULAR THERAPY. SCIENTIFIC REPORTS, 13(1). HTTPS://DOI.ORG/10.1038/S41598-023-42159-1 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 REVIEW, ALL PATIENTS RECEIVED IV CALCIUM GLUCONATE SOLUTION DURING T-CELL AND STEM CELL COLLECTIONS, WHICH IS STANDARD PRACTICE FOR THESE TYPES OF COLLECTIONS AND DOES NOT CONSTITUTE MEDICAL INTERVENTION. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "RISK ANALYSIS OF FLUCTUATING HYPERCALCEMIA AFTER LEUKAPHERESIS IN CELLULAR THERAPY" BY TOMOYASU JO, YASUYUKIARAI, TOSHIO KITAWAKI, MOMOKO NISHIKORI, CHISAKI MIZUMOTO, JUNYA KANDA, KOUHEIYAMASHITA, MIKI NAGAO, AKIFUMITAKAORI, KONDO POTENTIAL ADVERSE EVENT: IN (B)(4) SUBJECTS (B)(4), 1 H POST-LEUKAPHERESIS, ICA CONCENTRATION WAS ABOVE THE UPPER LIMIT OF NORMAL. IN (B)(4) SUBJECTS (B)(4), ICA CON-CENTRATION WAS BELOW THE LOWER LIMIT OF NORMAL RANGE AT THE END OF LEUKAPHERESIS, BUT ROSE ABOVE THE UPPER LIMIT OF THE NORMAL RANGE 1 H AFTER THE END OF LEUKAPHERESIS, WITH A PROMINENT RISE DURING THE FIRST HOUR AFTER THE END. THESE RESULTS SUGGEST THAT HYPERCALCEMIA OCCURS AFTER LEUKAPHERESIS IN THE MAJORITY OF SUBJECTS. CALCIUM SUPPLEMENTATION PROVIDED. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "RISK ANALYSIS OF FLUCTUATING HYPERCALCEMIA AFTER LEUKAPHERESIS IN CELLULAR THERAPY" BY TOMOYASU JO, YASUYUKIARAI, TOSHIO KITAWAKI, MOMOKO NISHIKORI, CHISAKI MIZUMOTO, JUNYA KANDA, KOUHEIYAMASHITA, MIKI NAGAO, AKIFUMITAKAORI KONDO POTENTIAL ADVERSE EVENT: IN 58 SUBJECTS (76.3%), 1 H POST-LEUKAPHERESIS, ICA CONCENTRATION WAS ABOVE THE UPPER LIMIT OF NORMAL. IN 33 SUBJECTS (43.3%), ICA CON-CENTRATION WAS BELOW THE LOWER LIMIT OF NORMAL RANGE AT THE END OF LEUKAPHERESIS, BUT ROSE ABOVE THE UPPER LIMIT OF THE NORMAL RANGE 1 H AFTER THE END OF LEUKAPHERESIS, WITH A PROMINENT RISE DURING THE FIRST HOUR AFTER THE END. THESE RESULTS SUGGEST THAT HYPERCALCEMIA OCCURS AFTER LEUKAPHERESIS IN THE MAJORITY OF SUBJECTS. CALCIUM SUPPLEMENTATION PROVIDED. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20106 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other