BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 20052196 · Received August 23, 2024

    Report

    Report Number
    1722028-2024-00355
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    September 8, 2021
    Report Date
    August 23, 2024
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583102200
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS STILL IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. ELENGA, N., VANTILCKE, V., MARTIN, E., CUADRO, E., SELLES, P., & BASSET, T. (2021). RED BLOOD CELL EXCHANGE IN CHILDREN WITH SICKLE CELL DISEASE. INTERNATIONAL JOURNAL OF HEMATOLOGY, 115(1), 107¿113. HTTPS://DOI.ORG/10.1007/S12185-021-03221-8.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. INVESTIGATION: LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME.  IT HAS BEEN DETERMINED THAT THE EVENT SUBMITTED ON THIS REPORT IS A DUPLICATE OF THE EVENT SUBMITTED ON REPORT 1722028-2021-00340. ELENGA, N., VANTILCKE, V., MARTIN, E., CUADRO, E., SELLES, P., & BASSET, T. (2021). RED BLOOD CELL EXCHANGE IN CHILDREN WITH SICKLE CELL DISEASE. INTERNATIONAL JOURNAL OF HEMATOLOGY, 115(1), 107¿113. HTTPS://DOI.ORG/10.1007/S12185-021-03221-8.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE, "RED BLOOD CELL EXCHANGE IN CHILDREN WITH SICKLE CELL DISEASE" BY ELENGA, N., VANTILCKE, V., MARTIN, E., CUADRO, E., SELLES, P., & BASSET, T., THE AIM OF THE STUDY WAS TO ASSESS THE EFFICACY OF RED BLOOD CELL EXCHANGE (RBCX) USING A SPECTRA OPTIA AUTOMATED APHERESIS SYSTEM IN CHILDREN WITH SICKLE CELL DISEASE (SCD). USING AUTOMATED RBCX TO TREAT ACUTE AND CHRONIC COMPLICATIONS IN 75 CHILDREN WITH SCD WHO HAD A MEDIAN AGE OF 10 YEARS [7¿13], 649 RBCX SESSIONS WERE ANALYZED. PERIPHERAL VENOUS ACCESS WAS LIMITED IN A NUMBER OF THE CHILDREN, AND THUS A FEMORAL DOUBLE-LUMEN CENTRAL VENOUS CATHETER, AND HEPARIN LOCKING WITH 500 UNITS IN EACH LUMEN OF THE CATHETER. TO PREVENT COMPLICATIONS, ALL PATIENTS HAD ACHIEVED A POST-RCE HB LEVEL OF <30%. FOR CHRONIC TRANSFUSION, WITH A POST-RCE HB LEVEL OF APPROXIMATELY 10¿11 G/DL, A BLOOD EXCHANGE VOLUME OF =32 ML/KG, AND AN INTERVAL BETWEEN EACH RBCX PROCEDURE OF =30 DAYS, THE RESIDUAL HBS LEVEL WAS MAINTAINED BELOW 30%. FOR ACUTE TRANSFUSION, A POST-EXCHANGE HB LEVEL =10 G/DL (P<0.001) AND A TOTAL EXCHANGE VOLUME =35 ML/KG (P=0.001) WAS THE BEST WAY TO REDUCE HBS TO<30%. AUC WAS 0.84. RESULTS SHOWED THAT ERYTHROCYTAPHERESIS WERE USEFUL AND SAFE FOR CHILDREN WITH SCD. HOWEVER, THREE EPISODES OF DEEP VEIN THROMBOSIS REQUIRING HEPARIN TREATMENT OCCURRED IN THREE PATIENTS. THESE THROMBOSES OCCURRED IN CHILDREN AGED 11, 12, AND 13 YEARS, WHO MAINTAINED THE CATHETER FOR MORE THAN 12 HRS AFTER THE END OF THE ERYTHROCYTAPHERESIS PROCEDURE. IN TWO CASES OF UNILATERAL THROMBOSIS OF THE FEMOROPOPLITEAL VEIN, THE EVOLUTION WAS RAPIDLY FAVORABLE AFTER REMOVAL OF THE CATHETER AND ANTICOAGULANT TREATMENT. THE THIRD PATIENT PRESENTED A BILATERAL ILIOFEMORAL-POPLITEAL VEIN THROMBOSIS, COMPLICATED BY A RIGHT PULMONARY EMBOLISM, DESPITE CATHETER REMOVAL. ADDITIONALLY, BETWEEN 2012 AND 2019, 19 CHILDREN (13 BOYS AND 6 GIRLS), WITH A MEDIAN AGE OF 8 [7¿10] YEARS WERE PLACED ON CHRONIC TRANSFUSION FOR STROKE PREVENTION. OF THESE, 17 HAD HOMOZYGOUS SCD AND TWO HAD SICKLE ¿0-THALASSAEMIA. NINE HAD A HISTORY OF STROKE AND TEN AN ABNORMAL TRANSCRANIAL DOPPLER (TCD) VELOCITY (AND NORMAL MAGNETIC RESONANCE IMAGING (MRI) BRAIN SCAN). SIDE EFFECTS AND COMPLICATIONS INCLUDED IRON OVERLOAD, NON-HAEMOLYTIC TRANSFUSION REACTION, THROMBOEMBOLIC COMPLICATIONS, ALLERGIC REACTION, ACUTE HAEMOLYTIC TRANSFUSION REACTION, PRESENCE OF BLOOD CLOTS IN THE CENTRAL CATHETER. ONE PATIENT DEVELOPED RED BLOOD CELL ALLOANTIBODIES. OF THE 17 PATIENTS, 4 REQUIRED IRON CHELATION. FOR 24% OF THE PATIENTS, THE HBS LEVEL WAS BELOW 30%. 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. THE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE, "RED BLOOD CELL EXCHANGE IN CHILDREN WITH SICKLE CELL DISEASE" BY ELENGA, N., VANTILCKE, V., MARTIN, E., CUADRO, E., SELLES, P., & BASSET, T., THE AIM OF THE STUDY WAS TO ASSESS THE EFFICACY OF RED BLOOD CELL EXCHANGE (RBCX) USING A SPECTRA OPTIA AUTOMATED APHERESIS SYSTEM IN CHILDREN WITH SICKLE CELL DISEASE (SCD). USING AUTOMATED RBCX TO TREAT ACUTE AND CHRONIC COMPLICATIONS IN 75 CHILDREN WITH SCD WHO HAD A MEDIAN AGE OF 10 YEARS [7¿13], 649 RBCX SESSIONS WERE ANALYZED. PERIPHERAL VENOUS ACCESS WAS LIMITED IN A NUMBER OF THE CHILDREN, AND THUS A FEMORAL DOUBLE-LUMEN CENTRAL VENOUS CATHETER, AND HEPARIN LOCKING WITH 500 UNITS IN EACH LUMEN OF THE CATHETER. TO PREVENT COMPLICATIONS, ALL PATIENTS HAD ACHIEVED A POST-RCE HB LEVEL OF <30%. FOR CHRONIC TRANSFUSION, WITH A POST-RCE HB LEVEL OF APPROXIMATELY 10¿11 G/DL, A BLOOD EXCHANGE VOLUME OF =32 ML/KG, AND AN INTERVAL BETWEEN EACH RBCX PROCEDURE OF =30 DAYS, THE RESIDUAL HBS LEVEL WAS MAINTAINED BELOW 30%. FOR ACUTE TRANSFUSION, A POST-EXCHANGE HB LEVEL =10 G/DL (P<0.001) AND A TOTAL EXCHANGE VOLUME =35 ML/KG (P=0.001) WAS THE BEST WAY TO REDUCE HBS TO<30%. AUC WAS 0.84. RESULTS SHOWED THAT ERYTHROCYTAPHERESIS WERE USEFUL AND SAFE FOR CHILDREN WITH SCD. HOWEVER, THREE EPISODES OF DEEP VEIN THROMBOSIS REQUIRING HEPARIN TREATMENT OCCURRED IN THREE PATIENTS. THESE THROMBOSES OCCURRED IN CHILDREN AGED 11, 12, AND 13 YEARS, WHO MAINTAINED THE CATHETER FOR MORE THAN 12 HRS AFTER THE END OF THE ERYTHROCYTAPHERESIS PROCEDURE. IN TWO CASES OF UNILATERAL THROMBOSIS OF THE FEMOROPOPLITEAL VEIN, THE EVOLUTION WAS RAPIDLY FAVORABLE AFTER REMOVAL OF THE CATHETER AND ANTICOAGULANT TREATMENT. THE THIRD PATIENT PRESENTED A BILATERAL ILIOFEMORAL-POPLITEAL VEIN THROMBOSIS, COMPLICATED BY A RIGHT PULMONARY EMBOLISM, DESPITE CATHETER REMOVAL. ADDITIONALLY, BETWEEN 2012 AND 2019, 19 CHILDREN (13 BOYS AND 6 GIRLS), WITH A MEDIAN AGE OF 8 [7¿10] YEARS WERE PLACED ON CHRONIC TRANSFUSION FOR STROKE PREVENTION. OF THESE, 17 HAD HOMOZYGOUS SCD AND TWO HAD SICKLE ¿0-THALASSAEMIA. NINE HAD A HISTORY OF STROKE AND TEN AN ABNORMAL TRANSCRANIAL DOPPLER (TCD) VELOCITY (AND NORMAL MAGNETIC RESONANCE IMAGING (MRI) BRAIN SCAN). SIDE EFFECTS AND COMPLICATIONS INCLUDED IRON OVERLOAD, NON-HAEMOLYTIC TRANSFUSION REACTION, THROMBOEMBOLIC COMPLICATIONS, ALLERGIC REACTION, ACUTE HAEMOLYTIC TRANSFUSION REACTION, PRESENCE OF BLOOD CLOTS IN THE CENTRAL CATHETER. ONE PATIENT DEVELOPED RED BLOOD CELL ALLOANTIBODIES. OF THE 17 PATIENTS, 4 REQUIRED IRON CHELATION. FOR 24% OF THE PATIENTS, THE HBS LEVEL WAS BELOW 30%. 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. THE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742201 SPECTRA OPTIA APHERESIS SYSTEM SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other