BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 18857998 · Received March 7, 2024

    Report

    Report Number
    1722028-2024-00074
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    January 7, 2024
    Report Date
    March 7, 2024
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. CITATION: EBEID, F. S. E. (2023). THE IMPLEMENTATION OF AUTOMATED RED BLOOD CELL EXCHANGE (ERYTHROCYTAPHERESIS) AS A TREATMENT MODALITY IN SICKLE CELL DISEASE PATIENTS: SINGLE CENTER EXPERIENCE. TRANSFUSION AND APHERESIS SCIENCE, 62(4), 103719. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2023.103719 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 FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: EBEID, F. S. E. (2023). THE IMPLEMENTATION OF AUTOMATED RED BLOOD CELL EXCHANGE (ERYTHROCYTAPHERESIS) AS A TREATMENT MODALITY IN SICKLE CELL DISEASE PATIENTS: SINGLE CENTER EXPERIENCE. TRANSFUSION AND APHERESIS SCIENCE, 62(4), 103719. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2023.103719.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "THE IMPLEMENTATION OF AUTOMATED RED BLOOD CELL EXCHANGE (ERYTHROCYTAPHERESIS) AS A TREATMENT MODALITY IN SICKLE CELL DISEASE PATIENTS: SINGLE CENTER EXPERIENCE" BY FATMA SOLIMAN ELSAYED EBEID IMPROVEMENTS OF HEALTH INFRASTRUCTURE, PREVENTIVE CARE AND CLINICAL MANAGEMENT IS IMPORTANT TO REDUCE THE MORBIDITY AND MORTALITY OF SICKLE CELL DISEASE (SCD). OBJECTIVE: THIS PROSPECTIVE, INVESTIGATOR-INITIATED NON-RANDOMIZED OPEN-LABEL INTERVENTION, SINGLE CENTRE STUDY DESCRIBES THE IMPLEMENTATION OF THE AUTOMATED ERYTHROCYTAPHERESIS IN LOW-MIDDLE INCOME COUNTRY AS A TREATMENT MODALITY FOR SCD PATIENTS TO IMPROVE THE STANDARD OF CARE AND HIGHLIGHTS ITS BENEFITS AND CHALLENGES. METHODOLOGY: ELIGIBLE PATIENTS WITH SCD WHO HAD OVERT STROKE, ABNORMAL/CONDITIONAL TRANSCRANIAL DOPPLER (TCD), OR OTHER INDICATIONS WERE SUBJECTED TO REGULAR AUTOMATED ERYTHROCYTAPHERESIS PROGRAM. RESULTS: FROM (B)(6) 2017 TILL (B)(6) 2022, 21 SUBJECTS WERE ENROLLED; SEVENTEEN (80.9 %) WERE EGYPTIAN AND FOUR (19.1 %) WERE NON-EGYPTIAN (THREE SUDANESE AND ONE NIGERIAN). TOTALLING 133 SESSIONS HAD BEEN PERFORMED MAINLY IN WORKING HOURS WITH FLUCTUATING FREQUENCY PER MONTH. ALL SESSIONS MAINTAINED ISOVOLUMIC STATUS AND WERE PERFORMED USING CENTRAL VENOUS ACCESS. THE TARGET HBS CONCENTRATION WAS SET FROM THE START; THE MEAN FINAL FCR % FRACTION WAS 51, MOST OF THE SESSION (N = 78, 58.7 %) WERE ABLE TO ACHIEVE TARGET FCR. THE MAJORITY OF SESSION PASS SMOOTHLY WITH NO ADVERSE EVENT (N = 81, 60.9 %), EXCEPT FOR CERTAIN CHALLENGES AS SHORTAGE OF THE REQUIRED BLOOD (N = 38), HYPOTENSION (N = 2), HYPOCALCAEMIA (N = 2). CONCLUSION: AUTOMATED ERYTHROCYTAPHERESIS IS SAFE AND EFFECTIVE MODALITY FOR MANAGEMENT OF PATIENTS WITH SICKLE CELL DISEASE. 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 "THE IMPLEMENTATION OF AUTOMATED RED BLOOD CELL EXCHANGE (ERYTHROCYTAPHERESIS) AS A TREATMENT MODALITY IN SICKLE CELL DISEASE PATIENTS: SINGLE CENTER EXPERIENCE" BY FATMA SOLIMAN ELSAYED EBEID IMPROVEMENTS OF HEALTH INFRASTRUCTURE, PREVENTIVE CARE AND CLINICAL MANAGEMENT IS IMPORTANT TO REDUCE THE MORBIDITY AND MORTALITY OF SICKLE CELL DISEASE (SCD). OBJECTIVE: THIS PROSPECTIVE, INVESTIGATOR-INITIATED NON-RANDOMIZED OPEN-LABEL INTERVENTION, SINGLE CENTRE STUDY DESCRIBES THE IMPLEMENTATION OF THE AUTOMATED ERYTHROCYTAPHERESIS IN LOW-MIDDLE INCOME COUNTRY AS A TREATMENT MODALITY FOR SCD PATIENTS TO IMPROVE THE STANDARD OF CARE AND HIGHLIGHTS ITS BENEFITS AND CHALLENGES. METHODOLOGY: ELIGIBLE PATIENTS WITH SCD WHO HAD OVERT STROKE, ABNORMAL/CONDITIONAL TRANSCRANIAL DOPPLER (TCD), OR OTHER INDICATIONS WERE SUBJECTED TO REGULAR AUTOMATED ERYTHROCYTAPHERESIS PROGRAM. RESULTS: FROM 18TH DEC 2017 TILL 17TH DEC 2022, 21 SUBJECTS WERE ENROLLED; SEVENTEEN (80.9 %) WERE EGYPTIAN AND FOUR (19.1 %) WERE NON-EGYPTIAN (THREE SUDANESE AND ONE NIGERIAN). TOTALLING 133 SESSIONS HAD BEEN PERFORMED MAINLY IN WORKING HOURS WITH FLUCTUATING FREQUENCY PER MONTH. ALL SESSIONS MAINTAINED ISOVOLUMIC STATUS AND WERE PERFORMED USING CENTRAL VENOUS ACCESS. THE TARGET HBS CONCENTRATION WAS SET FROM THE START; THE MEAN FINAL FCR % FRACTION WAS 51, MOST OF THE SESSION (N = 78, 58.7 %) WERE ABLE TO ACHIEVE TARGET FCR. THE MAJORITY OF SESSION PASS SMOOTHLY WITH NO ADVERSE EVENT (N = 81, 60.9 %), EXCEPT FOR CERTAIN CHALLENGES AS SHORTAGE OF THE REQUIRED BLOOD (N = 38), HYPOTENSION (N = 2), HYPOCALCAEMIA (N = 2). CONCLUSION: AUTOMATED ERYTHROCYTAPHERESIS IS SAFE AND EFFECTIVE MODALITY FOR MANAGEMENT OF PATIENTS WITH SICKLE CELL DISEASE. 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
    2163378 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other