BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 15183360 · Received August 8, 2022

    Report

    Report Number
    1722028-2022-00256
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    January 1, 2022
    Report Date
    August 8, 2022
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583103108
    PMA / PMN Number
    BK150251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER, MANUFACTURE AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: APHERESIS COLLECTION OF HAEMATOPOIETIC STEM CELLS FROM PERIPHERAL BLOOD IN ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES-MACEDONIAN EXPERIENCE. VOX SANGUINIS. 2022. 117(SUPPL 1):249 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. 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. NO MEDICAL INTERVENTION WAS REPORTED FOR THIS EVENT. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT. ARTICLE CITATION: APHERESIS COLLECTION OF HAEMATOPOIETIC STEM CELLS FROM PERIPHERAL BLOOD IN ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES-MACEDONIAN EXPERIENCE. VOX SANGUINIS. 2022. 117(SUPPL 1):249.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, "APHERESIS COLLECTION OF HAEMATOPOIETIC STEM CELLS FROM PERIPHERAL BLOOD IN ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES-MACEDONIAN EXPERIENCE" DESCRIBES A STUDY THAT PRESENTS A SINGLE SITE'S EXPERIENCE WITH COLLECTING OF MOBILIZED PERIPHERAL BLOOD STEM CELL (PBSC) IN ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES. PBSC COLLECTION WAS PERFORMED WITH CONTINUOUS FLOW CELL SEPARATOR BAXTER C53000, COBE SPECTRA AND TERUMO BCT SPECTRA OPTIA USING CONVENTIONAL-VOLUME APHERESIS PROCESSING THE 2¿2.5 TOTAL BLOOD VOLUMES PER APHERESIS. A FEMORAL CATHETER WAS USED FOR COLLECTION OF PBSC. ACID CITRATE DEXTROSE FORMULA A (ACD-A) IS USED FOR ANTICOAGULATION DURING APHERESIS COLLECTION. MOBILIZATION REGIMENS INCLUDED GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF) ALONE OR COMBINATION OF G-CSF AND DISEASE-SPECIFIC CHEMOTHERAPY. THERE WERE 792 APHERESIS PROCEDURES PERFORMED IN 448 HEMATOLOGIC PATIENTS, AGED 16¿65. THE SINGLE PROCEDURE USUALLY TOOK 180¿270¿MIN AND THE VOLUME OF COLLECTED STEM CELLS WAS 50¿380¿ML. THE ARTICLE STATES THAT, "PROCEDURES FOR MOBILIZATION AND COLLECTION OF PBPC WERE GENERALLY WELL TOLERATED." IT IS UNKNOWN IF THERE WERE PROCEDURES THAT WERE NOT WELL TOLERATED AND IF ANY MEDICAL INTERVENTION WAS NECESSARY. PATIENT INFORMATION IS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THE DISPOSABLE SETS ARE NOT AVAILABLE FOR RETURN FROM THE CUSTOMER.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, "APHERESIS COLLECTION OF HAEMATOPOIETIC STEM CELLS FROM PERIPHERAL BLOOD IN ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES-MACEDONIAN EXPERIENCE" DESCRIBES A STUDY THAT PRESENTS A SINGLE SITE'S EXPERIENCE WITH COLLECTING OF MOBILIZED PERIPHERAL BLOOD STEM CELL (PBSC) IN ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES. PBSC COLLECTION WAS PERFORMED WITH CONTINUOUS FLOW CELL SEPARATOR BAXTER C53000, COBE SPECTRA AND TERUMO BCT SPECTRA OPTIA USING CONVENTIONAL-VOLUME APHERESIS PROCESSING THE 2¿2.5 TOTAL BLOOD VOLUMES PER APHERESIS. A FEMORAL CATHETER WAS USED FOR COLLECTION OF PBSC. ACID CITRATE DEXTROSE FORMULA A (ACD-A) IS USED FOR ANTICOAGULATION DURING APHERESIS COLLECTION. MOBILIZATION REGIMENS INCLUDED GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF) ALONE OR COMBINATION OF G-CSF AND DISEASE-SPECIFIC CHEMOTHERAPY. THERE WERE 792 APHERESIS PROCEDURES PERFORMED IN 448 HEMATOLOGIC PATIENTS, AGED 16¿65. THE SINGLE PROCEDURE USUALLY TOOK 180¿270¿MIN AND THE VOLUME OF COLLECTED STEM CELLS WAS 50¿380¿ML. THE ARTICLE STATES THAT, "PROCEDURES FOR MOBILIZATION AND COLLECTION OF PBPC WERE GENERALLY WELL TOLERATED." IT IS UNKNOWN IF THERE WERE PROCEDURES THAT WERE NOT WELL TOLERATED AND IF ANY MEDICAL INTERVENTION WAS NECESSARY. PATIENT INFORMATION IS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THE DISPOSABLE SETS ARE NOT AVAILABLE FOR RETURN FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090570 SPECTRA OPTIA SPECTRA OPTIA IDL SET GKT TERUMO BCT 10310 05020583103108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other