BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 15815756 · Received November 17, 2022

    Report

    Report Number
    1722028-2022-00369
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    April 5, 2022
    Report Date
    November 17, 2022
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583101203
    PMA / PMN Number
    BK150251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: OJHA, S., POOJARY, M., MOKALIKAR, U., SUMATHI, S.H., KUMAR, A., GUPTA, A.M., AND SAHA, S. THE DETERMINANTS OF DONOR SAFETY AND PRODUCT QUALITY IN OPTIMIZATION OF APHERESIS GRANULOCYTE HARVEST: AN EXPERIENCE FROM A TERTIARY CARE ONCOLOGY CENTRE IN INDIA, TRANSFUSION AND APHERESIS SCIENCE, (2022) DOI:HTTPS://DOI.ORG/10.1016/J.TRANSCI.2022.103445. 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 LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: OJHA, S., POOJARY, M., MOKALIKAR, U., SUMATHI, S.H., KUMAR, A., GUPTA, A.M., AND SAHA, S. THE DETERMINANTS OF DONOR SAFETY AND PRODUCT QUALITY IN OPTIMIZATION OF APHERESIS GRANULOCYTE HARVEST: AN EXPERIENCE FROM A TERTIARY CARE ONCOLOGY CENTRE IN INDIA, TRANSFUSION AND APHERESIS SCIENCE, (2022) DOI:HTTPS://DOI.ORG/10.1016/J.TRANSCI.2022.103445 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. IT WAS CONFIRMED THAT THERE WAS NO MENTION OF MEDICAL INTERVENTION FOR THE CITRATE TOXICITY. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, 'THE DETERMINANTS OF DONOR SAFETY AND PRODUCT QUALITY IN OPTIMIZATION OF APHERESIS GRANULOCYTE HARVEST: AN EXPERIENCE FROM A TERTIARY CARE ONCOLOGY CENTRE IN INDIA' DESCRIBES A RETROSPECTIVE STUDY ON 131 HEALTHY ALLOGENEIC DONORS WHO UNDERWENT GRANULOCYTE HARVEST FROM MAY 2016 TO JULY 2020. DONORS WERE MOBILIZED FOR GRANULOCYTE HARVEST 10-12 HOURS BEFORE COLLECTION WITH 10 ¿G/KG SUBCUTANEOUS INJECTION OF G-CSF PLUS 8 MG ORAL DEXAMETHASONE TABLETS AND WERE SUBJECTED TO APHERESIS COLLECTION USING DIFFERENT CELL SEPARATORS LIKE COBE SPECTRA MNC SYSTEM (TERUMO BCT), FRESENIUS COM.TEC MNC SYSTEM (FRESENIUS KABI), AND SPECTRA OPTIA MNC SYSTEM (TERUMO BCT). DONOR'S AGES RANGED BETWEEN 20 TO 55 YEARS WITH A MEDIAN AGE OF 32 YEARS AND INCLUDED 129 MALES AND TWO FEMALE DONORS. ADVERSE EVENTS (AES) WERE OBSERVED IN OVERALL 29 PROCEDURES (22.13%), INCLUDING 14.50% CITRATE REACTIONS, 7.6% VENOUS ACCESS-RELATED REACTIONS, AND 1.52% VASOVAGAL REACTIONS. ALL THE AES WERE CLASSIFIED AS GRADE I AND GRADE II AS PER THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADING VERSION 5.0, WHICH REQUIRED MINIMAL INTERVENTION. - IV CALCIUM FOR REACTION. THE ARTICLE DID NOT PROVIDE SPECIFIC PATIENT INFORMATION, THEREFORE THIS REPORT IS BEING PROVIDED AS SUMMARY OF EVENTS. THE COLLECTION SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, 'THE DETERMINANTS OF DONOR SAFETY AND PRODUCT QUALITY IN OPTIMIZATION OF APHERESIS GRANULOCYTE HARVEST: AN EXPERIENCE FROM A TERTIARY CARE ONCOLOGY CENTRE IN INDIA' DESCRIBES A RETROSPECTIVE STUDY ON 131 HEALTHY ALLOGENEIC DONORS WHO UNDERWENT GRANULOCYTE HARVEST FROM MAY 2016 TO JULY 2020. DONORS WERE MOBILIZED FOR GRANULOCYTE HARVEST 10-12 HOURS BEFORE COLLECTION WITH 10 ¿G/KG SUBCUTANEOUS INJECTION OF G-CSF PLUS 8 MG ORAL DEXAMETHASONE TABLETS AND WERE SUBJECTED TO APHERESIS COLLECTION USING DIFFERENT CELL SEPARATORS LIKE COBE SPECTRA MNC SYSTEM (TERUMO BCT), FRESENIUS COM.TEC MNC SYSTEM (FRESENIUS KABI), AND SPECTRA OPTIA MNC SYSTEM (TERUMO BCT). DONOR'S AGES RANGED BETWEEN 20 TO 55 YEARS WITH A MEDIAN AGE OF 32 YEARS AND INCLUDED 129 MALES AND TWO FEMALE DONORS. ADVERSE EVENTS (AES) WERE OBSERVED IN OVERALL 29 PROCEDURES (22.13%), INCLUDING 14.50% CITRATE REACTIONS, 7.6% VENOUS ACCESS-RELATED REACTIONS, AND 1.52% VASOVAGAL REACTIONS. ALL THE AES WERE CLASSIFIED AS GRADE I AND GRADE II AS PER THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADING VERSION 5.0, WHICH REQUIRED MINIMAL INTERVENTION. - IV CALCIUM FOR REACTION. THE ARTICLE DID NOT PROVIDE SPECIFIC PATIENT INFORMATION, THEREFORE THIS REPORT IS BEING PROVIDED AS SUMMARY OF EVENTS. THE COLLECTION SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192953 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET GKT TERUMO BCT 10120 05020583101203

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other