BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTA OPTIA

    MDR report key: 14119424 · Received April 15, 2022

    Report

    Report Number
    1722028-2022-00128
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    July 7, 2021
    Report Date
    April 15, 2022
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583103108
    PMA / PMN Number
    BK150251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: ANELISE B. ARAÚJO *, GABRIELLE D. SALTON, MELISSA H. ANGELI, JULIANA M. FURLAN, TISSIANA SCHMALFUSS, LIANE M. ROHSIG. 2021. EFFECTS OF CELL CONCENTRATION, TIME OF FRESH STORAGE, AND CRYOPRESERVATION ON PERIPHERAL BLOOD STEM CELLS PBSC FRESH STORAGE AND CRYOPRESERVATION. TRANSFUSION AND APHERESIS SCIENCE. 61(2022)103298. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2021.103298 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.10. CORRECTED INFORMATION IS PROVIDED IN D.4. LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: ANELISE B. ARAÚJO *, GABRIELLE D. SALTON, MELISSA H. ANGELI, JULIANA M. FURLAN, TISSIANA SCHMALFUSS, LIANE M. ROHSIG. 2021. EFFECTS OF CELL CONCENTRATION, TIME OF FRESH STORAGE, AND CRYOPRESERVATION ON PERIPHERAL BLOOD STEM CELLS PBSC FRESH STORAGE AND CRYOPRESERVATION. TRANSFUSION AND APHERESIS SCIENCE. 61(2022)103298. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2021.103298 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. IT WAS CONFIRMED THAT THE ADVERSE REACTIONS WERE ATTRIBUTED TO DMSO USED TO CRYOPRESERVE THE STEM CELLS. THE ISSUES AT HANDS HAD TO DO WITH LOWER VIABILITY AND LOWER RECOVERY DUE TO THE HIGH STARTING STEM CELL CONCENTRATION IN PRODUCTS AND LONGER STORAGE TIME. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, 'EFFECTS OF CELL CONCENTRATION, TIME OF FRESH STORAGE, AND CRYOPRESERVATION ON PERIPHERAL BLOOD STEM CELLS PBSC FRESH STORAGE AND CRYOPRESERVATION' DISCUSSES A PROSPECTIVE STUDY THAT LOOKED AT THE QUALITY OF THE PERIPHERAL BLOOD STEM CELLS (PBSCS) PRODUCT DIRECTLY AND HOW IT IMPACTS CLINICAL OUTCOMES, AND HOW THE CELL QUALITY AND/OR FUNCTIONALITY MAY BE INFLUENCED BY THE STORAGE CONDITIONS AS TIME, TEMPERATURE, TOTAL NUCLEATED CELLS (TNC) CONCENTRATION AND CRYOPRESERVATION REQUIREMENT. PBSC SAMPLES (N = 11) WERE COLLECTED FROM 2018 TO 2020, USING AN AUTOMATED APHERESIS SYSTEM (COBE SPECTRA OPTIA, TERUMO BCT, USA). THE SAMPLES INCLUDED AUTOLOGOUS GRAFTS FROM MALES (5) AND FEMALES (6), WITH DIAGNOSIS OF MULTIPLE MYELOMA (7), LYMPHOMA (3) AND ACUTE MYELOID LEUKEMIA (1). THE PATIENT¿S MEDIAN AGE WAS 49,6 YEARS (RANGE, 28¿72 YEARS). EXACT DETAILS OF ANY EVENTS, IF MEDICAL INTERVENTION WAS NECESSARY, OR PATIENT INFORMATION IS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY. DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, 'EFFECTS OF CELL CONCENTRATION, TIME OF FRESH STORAGE, AND CRYOPRESERVATION ON PERIPHERAL BLOOD STEM CELLS PBSC FRESH STORAGE AND CRYOPRESERVATION' DISCUSSES A PROSPECTIVE STUDY THAT LOOKED AT THE QUALITY OF THE PERIPHERAL BLOOD STEM CELLS (PBSCS) PRODUCT DIRECTLY AND HOW IT IMPACTS CLINICAL OUTCOMES, AND HOW THE CELL QUALITY AND/OR FUNCTIONALITY MAY BE INFLUENCED BY THE STORAGE CONDITIONS AS TIME, TEMPERATURE, TOTAL NUCLEATED CELLS (TNC) CONCENTRATION AND CRYOPRESERVATION REQUIREMENT. PBSC SAMPLES (N = 11) WERE COLLECTED FROM 2018 TO 2020, USING AN AUTOMATED APHERESIS SYSTEM (COBE SPECTRA OPTIA, TERUMO BCT, USA). THE SAMPLES INCLUDED AUTOLOGOUS GRAFTS FROM MALES (5) AND FEMALES (6), WITH DIAGNOSIS OF MULTIPLE MYELOMA (7), LYMPHOMA (3) AND ACUTE MYELOID LEUKEMIA (1). THE PATIENT¿S MEDIAN AGE WAS 49,6 YEARS (RANGE, 28¿72 YEARS). EXACT DETAILS OF ANY EVENTS, IF MEDICAL INTERVENTION WAS NECESSARY, OR PATIENT INFORMATION IS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY. DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246707 SPECTA OPTIA SPECTRA OPTIA EXCHANGE SET,EA GKT TERUMO BCT 10220 NOT PROVIDED 05020583103108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other