BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 14270043 · Received May 3, 2022

    Report

    Report Number
    1722028-2022-00141
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    July 31, 2020
    Report Date
    May 2, 2022
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583102200
    PMA / PMN Number
    K183081
    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. INVESTIGATION: PER THE ARTICLE, 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. ALL PROCEDURES WERE PERFORMED BY PERIPHERAL ANTECUBITAL VEINS. THE PROCEDURES WERE PERFORMED FOR 80 TO 180 MINUTES WITH 5 TO 17 LITERS OF WHOLE BLOOD PROCESSING. ACID CITRATE DEXTROSE (ACD) WAS USED IN A RATIO BETWEEN 1:10 TO 1:13 WITH CONTINUOUS MONITORING OF CITRATE TOXICITY THROUGHOUT THE PROCEDURES. THERE WAS A SIGNIFICANT CORRELATION OBSERVED BETWEEN DONOR DEMOGRAPHIC PARAMETERS LIKE OLDER AGE (P =0.012) AND HIGHER BMI (P= 0.015) WITH A HIGHER NUMBER OF TOTAL AES. ALSO, A POSITIVE CORRELATION WAS SEEN BETWEEN DONOR BMI(P=0.004) AND VENOUS ACCESS-RELATED AES, WHILE NO ASSOCIATION WAS OBSERVED WITH THE REST OF THE PARAMETERS. THERE WAS A POSSIBLE CORRELATION OBSERVED BETWEEN THE OLDER AGE OF THE DONOR AND CITRATE-RELATED AES; HOWEVER, IT WAS NOT STATISTICALLY SIGNIFICANT(P=0.054). THE REST OF THE DONOR DEMOGRAPHIC PARAMETERS HAD NO SIGNIFICANT ASSOCIATION WITH THE CITRATE REACTIONS. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED. ARTICLE CITATION: SHASHANK OJHA, MINAL POOJARY, UMAKANT MOKALIKAR, S.H SUMATHI, ARUN KUMAR, ABHAYKUMAR MALIND GUPTA AND SURYATAPA SAHA, 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.

    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. INVESTIGATION: PER THE ARTICLE, 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. ALL PROCEDURES WERE PERFORMED BY PERIPHERAL ANTECUBITAL VEINS. THE PROCEDURES WERE PERFORMED FOR 80 TO 180 MINUTES WITH 5 TO 17 LITERS OF WHOLE BLOOD PROCESSING. ACID CITRATE DEXTROSE (ACD) WAS USED IN A RATIO BETWEEN (B)(4) WITH CONTINUOUS MONITORING OF CITRATE TOXICITY THROUGHOUT THE PROCEDURES. THERE WAS A SIGNIFICANT CORRELATION OBSERVED BETWEEN DONOR DEMOGRAPHIC PARAMETERS LIKE OLDER AGE (P =(B)(4)) AND HIGHER BMI (P= (B)(4)) WITH A HIGHER NUMBER OF TOTAL AES. ALSO, A POSITIVE CORRELATION WAS SEEN BETWEEN DONOR BMI(P=(B)(4)) AND VENOUS ACCESS-RELATED AES, WHILE NO ASSOCIATION WAS OBSERVED WITH THE REST OF THE PARAMETERS. THERE WAS A POSSIBLE CORRELATION OBSERVED BETWEEN THE OLDER AGE OF THE DONOR AND CITRATE-RELATED AES; HOWEVER, IT WAS NOT STATISTICALLY SIGNIFICANT(P=(B)(4)). THE REST OF THE DONOR DEMOGRAPHIC PARAMETERS HAD NO SIGNIFICANT ASSOCIATION WITH THE CITRATE REACTIONS. ARTICLE CITATION: SHASHANK OJHA, MINAL POOJARY, UMAKANT MOKALIKAR, S.H SUMATHI, ARUN KUMAR, ABHAYKUMAR MALIND GUPTA AND SURYATAPA SAHA, 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. 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 WERE NO SERIOUS ADVERSE EVENTS AND NO MENTION OF ANY MEDICAL INTERVENTION IN THE ARTICLE. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE STUDY IN THE 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', ANALYZED RETROSPECTIVE DATA OF 131 HEALTHY ALLOGENEIC DONORS WHO UNDERWENT GRANULOCYTE HARVEST FROM MAY 2016 TO JULY 2020. THE CELL SEPARATORS USED WERE COBE SPECTRA MNC SYSTEM (TERUMO BCT) (44 PROCEDURES) , FRESENIUS COM.TEC MNC SYSTEM (FRESENIUS KABI) (63 PROCEDURES), AND SPECTRA OPTIA MNC SYSTEM (TERUMO BCT) (24 PROCEDURES). PER THE ARTICLE, ADVERSE EVENTS (AES) WERE OBSERVED IN OVERALL 31 PROCEDURES (22.13%), INCLUDING 19(14.50%) CITRATE REACTIONS, 10(7.6%) VENOUS ACCESS-RELATED REACTIONS, AND 2(1.52%) VASOVAGAL REACTIONS. ALL THE DONORS SUCCESSFULLY DONATED AND TOLERATED GRANULOCYTE COLONY STIMULATING FACTOR PLUS DEXAMETHASONE MOBILIZATION AND GRANULOCYTE APHERESIS HARVEST WITHOUT ANY SERIOUS AES. ALL THE PROCEDURE-RELATED AES WERE MANAGED BY TRANSFUSION MEDICINE SPECIALISTS. DONOR'S AGES RANGED BETWEEN 20 TO 55 YEARS WITH A MEDIAN AGE OF 32 YEARS AND INCLUDED 129 MALES AND TWO FEMALE DONORS. EXACT PATIENT INFORMATION OR INFORMATION REGARDING ANY MEDICAL INTERVENTION NEEDED FOR THE ADVERSE EVENTS, WAS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF EVENTS. THE DEVICES ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Description of Event or Problem · 0

    THE STUDY IN THE 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', ANALYZED RETROSPECTIVE DATA OF (B)(4) HEALTHY ALLOGENEIC DONORS WHO UNDERWENT GRANULOCYTE HARVEST FROM (B)(6) 2016 TO (B)(6) 2020. THE CELL SEPARATORS USED WERE COBE SPECTRA MNC SYSTEM (TERUMO BCT) ((B)(4) PROCEDURES) , FRESENIUS COM.TEC MNC SYSTEM (FRESENIUS KABI) ((B)(4)PROCEDURES), AND SPECTRA OPTIA MNC SYSTEM (TERUMO BCT) ((B)(4) PROCEDURES). PER THE ARTICLE, ADVERSE EVENTS (AES) WERE OBSERVED IN OVERALL (B)(4) PROCEDURES ((B)(4)), INCLUDING (B)(4) ((B)(4)) CITRATE REACTIONS, (B)(4)((B)(4)) VENOUS ACCESS-RELATED REACTIONS, AND (B)(4) ((B)(4)) VASOVAGAL REACTIONS. ALL THE DONORS SUCCESSFULLY DONATED AND TOLERATED GRANULOCYTE COLONY STIMULATING FACTOR PLUS DEXAMETHASONE MOBILIZATION AND GRANULOCYTE APHERESIS HARVEST WITHOUT ANY SERIOUS AES. ALL THE PROCEDURE-RELATED AES WERE MANAGED BY TRANSFUSION MEDICINE SPECIALISTS. DONOR'S AGES RANGED BETWEEN 20 TO 55 YEARS WITH A MEDIAN AGE OF 32 YEARS AND INCLUDED (B)(4)MALES AND (B)(4) FEMALE DONORS. EXACT PATIENT INFORMATION OR INFORMATION REGARDING ANY MEDICAL INTERVENTION NEEDED FOR THE ADVERSE EVENTS, WAS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF EVENTS. THE DEVICES ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074139 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 10220 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other