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Per journal article "successful stem cell apheresis using spectra optia in a 6¿kg child with atypical teratoid/rhabdoid tumor" by patrick brust, claudia schubert, martin blohm, and beate winkler, summary: peripheral blood stem cell apheresis has become a routine procedure for the collection of peripheral blood stem cells to enable high-dose chemotherapy followed by autologous stem cell transplantation in high-risk pediatric malignancies.However, the procedure remains challenging in very low-weight infants due to high extracorporeal blood volume and citrate toxicity.Our case report demonstrates in detail a successful and complication-free largevolume leukapheresis in a very small infant weighing 6 kg using a spectra optia apheresis system after placing a femoral doublelumen shaldon catheter.Anticoagulation was achieved by citrate dextrose solution without the use of heparin.The total amount of blood being processed during the procedure equaled almost 4 times the total blood volume of the patient.The final apheresis product contained 14.0×106 cd34+ cells/kg body weight.The infant was diagnosed with an atypical teratoid/rhabdoid tumor of the thalamus and third ventricle at the age of 3 months and had a history of epileptic seizures.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 the collection set is not available for return because it was discarded by the customer.
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Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: brust, p., schubert, c., blohm, m., & winkler, b.(2020).Successful stem cell apheresis using spectra optia in a 6 kg child with atypical teratoid/rhabdoid tumor. journal of pediatric hematology/oncology, 42(7), e692¿e695. https://doi.Org/10.1097/mph.0000000000001745.
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This report is being filed to provide additional information in b.5,h.6 and h.11 and corrected information in a.2 and d2.B.Overview: an investigation was conducted for journal article that references terumo bct product.Journal article, titled ¿successful stem cell apheresis using spectra optia in a 6 kg child with atypical teratoid/rhabdoid tumor¿ by winkler et al.Mar 2023, was reviewed with primary purpose of screening for allegations of terumo bct device causing or contributing to death/injury or device malfunctions.Product evaluation: part evaluation is not feasible for this journal article investigation because there are many months between collection of data, to peer review, to final publication.Investigational details: the purpose of the journal article study is noted in the article abstract: peripheral blood stem cell apheresis has become a routine procedure for the collection of peripheral blood stem cells to enable high-dose chemotherapy followed by autologous stem cell transplantation in high-risk pediatric malignancies.However, the procedure remains challenging in very low-weight infants due to high extracorporeal blood volume and citrate toxicity.Our case report demonstrates in detail a successful and complication-free largevolume leukapheresis in a very small infant weighing 6 kg using a spectra optia apheresis system after placing a femoral doublelumen shaldon catheter.Anticoagulation was achieved by citrate dextrose solution without the use of heparin.The total amount of blood being processed during the procedure equaled almost 4 times the total blood volume of the patient.The final apheresis product contained 14.0×106 cd34+ cells/kg body weight.The infant was diagnosed with an atypical teratoid/rhabdoid tumor of the thalamus and third ventricle at the age of 3 months and had a history of epileptic seizures.Summary of terumo bct product in relation to the journal article: regarding terumo bct product, optia, possible complications (including hypotension and hemodynamic instability due to large ebv and fluid shifts, bleeding from venipuncture, coagulation disorders and thrombocytopenia, hypocalcemia-related neurological and gastrointestinal complications as well as cardiac dysrhythmia due to citrate toxicity) were listed, however were not encountered during the procedure.However, the patient developed pyrexia up to 38.7°c in the night after the procedure and antibiotic treatment was initiated.This case report focusses on the technical details regarding stem cell apheresis in an infant with at/rt weighing only 6 kg using the spectra optia apheresis system.On the day of apheresis, the patient was 6 months old.His exact body weight was 6.3 kg.Central vascular access was established by placing a doublelumen shaldon catheter (6.5 f, 10 cm; gamcath gambro, hechingen, germany) into the right femoral vein in the morning before leukapheresis.During catheter insertion and stem cell apheresis, the patient was intubated and mechanically ventilated using morphine and midazolam for analgosedation.Spectra optia version 11, mnc program (terumo bct) was used to collect pbsc.The collection goal was 2 products containing 2 to 4×106 cd34+ cells/kg body weight each.The cell separator was prefilled with irradiated leukocyte-depleted packed red blood cells and a blood warmer was used to avoid hypothermia as the blood flow was very low.Ebv was 190ml compared with an estimated tbv of 480ml of the patient.Noninvasive blood pressure was 72/27mmhg, pulse was 123 bpm at the beginning of apheresis and remained stable throughout the stem cell collection.Citrate dextrose solution a (acd-a) was used as an infusion to achieve proper anticoagulation at a ratio of 1:14 to whole blood.The inlet flow rate was 10ml/min during the whole procedure.The anticoagulant flow was 0.7ml/min and the collection rate was 0.8 ml/min.Citrate related hypocalcemia was premediaited and managed by calcium gluconate supplemented continuously: 10ml calcium gluconate 10% (2.25mmol calcium) were diluted in 40ml of 0.9% saline solution and, at an initial ionized calcium level of 1.33mmol/l, infused by 3.5ml/h.Repeated measurements of ionized calcium were performed every 20 to 40 minutes and calcium supply was increased accordingly as shown in table 2 to up to 8.5ml/h (equivalent to a maximum infusion rate of 0.38mmol/h or 0.06mmol/ kg body weight/h).The customer observed a slight decrease in ionized calcium without clinical signs of hypocalcemia.During the stem cell harvest, a clearly prolonged thrombin time and some inr elevation was observed, indicating an increased bleeding propensity.Those coagulation disturbances resolved spontaneously and without intervention after completion of apheresis.Monitored vital parameters (noninvasive blood pressure, heart rate, temperature, oxygen saturation) remained stable during the procedure.There were no clinical signs of volume overload and no diuretic treatment was necessary.No catheter-related problems occurred.Apheresis was completed after 198 minutes and a total of 1879ml blood was processed, which corresponds to almost 4 times the patient´s tbv.The customer performed 2 apheresis chamber collections during which collected volumes of the apheresis chamber were 17 and 22ml, respectively, which were flushed with 3 ml each time.The collected product volume was 45ml.Consumption of acd-a was 147ml, of which 123ml were infused into the patient.Five milliliters of anticoagulants were accumulated in the collection bag.The final product contained 2211 cd34+ cells/¿l which corresponded to 14.0×106 stem cells/kg body weight.After apheresis cd34+ count was 160/¿l in the patient¿s peripheral blood, indicating that stem cell mobilization had continued during the procedure.The calculated collection efficacy was 31.4%.The patient was discharged from our pediatric intensive care unit on the evening of the day of harvest with stable hemodynamics and in excellent clinical condition.However, the patient developed pyrexia up to 38.7°c in the night after the procedure and antibiotic treatment was initiated.Blood cultures remained negative and c-reactive protein was not elevated.The next chemotherapy cycle was started 2 days after apheresis.Four days after the procedure, the boy was discharged home.Unfortunately, response assessment by magnetic resonance imaging just before the planned hdct showed a new cerebellar metastasis.The patient died at the age of 11 months due to tumor progression.In conclusion, this case report demonstrates the technical feasibility of complication-free lvla in a very small child of 6 kg body weight using the spectra optia apheresis system.With precise monitoring of vital signs, electrolytes and coagulation parameters and adequate adjustment of calcium gluconate infusion, the procedure is safe and can be well tolerated even in a very small infant with a large brain tumor after multiple major chemotherapy cycles.Disposables lot history: since this was a journal publication to establish an institutional protocol for intra-operative therapeutic plasma exchange (tpe) performed on the spectra optia platform from 2017 onwards, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.Since this was a journal publication to establish an institutional protocol for intra-operative therapeutic plasma exchange (tpe) performed on the spectra optia platform from 2017 onwards, the lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension root cause: a root cause assessment was performed for the adverse reactions (fever).Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient¿s reactions to the mobilization regimen * patient¿s underlying disease state citation: brust, p., schubert, c., blohm, m., & winkler, b.(2020).Successful stem cell apheresis using spectra optia in a 6 kg child with atypical teratoid/rhabdoid tumor.Journal of pediatric hematology/oncology, 42(7), e692¿e695.Https://doi.Org/10.1097/mph.0000000000001745.
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Per journal article "successful stem cell apheresis using spectra optia in a 6 kg child with atypical teratoid/rhabdoid tumor" by patrick brust, claudia schubert, martin blohm, and beate winkler, summary: peripheral blood stem cell apheresis has become a routine procedure for the collection of peripheral blood stem cells to enable high-dose chemotherapy followed by autologous stem cell transplantation in high-risk pediatric malignancies.However, the procedure remains challenging in very low-weight infants due to high extracorporeal blood volume and citrate toxicity.Our case report demonstrates in detail a successful and complication-free largevolume leukapheresis in a very small infant weighing 6 kg using a spectra optia apheresis system after placing a femoral doublelumen shaldon catheter.Anticoagulation was achieved by citrate dextrose solution without the use of heparin.The total amount of blood being processed during the procedure equaled almost 4 times the total blood volume of the patient.The final apheresis product contained 14.0×106 cd34+ cells/kg body weight.The infant was diagnosed with an atypical teratoid/rhabdoid tumor of the thalamus and third ventricle at the age of 3 months and had a history of epileptic seizures.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.Since this was a journal publication to establish an institutional protocol for intra-operative therapeutic plasma exchange (tpe) performed on the spectra optia platform from 2017 onwards.A request for specific patient information is not feasible.The collection set is not available for return because it was discarded by the customer.
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