MAUDE Adverse Event Report: Terumo BCT Spectra Optia; SPECTRA OPTIA EXCHANGE SET

Catalog Number	4102201
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, manufacture date and expiry date are not available at this time.Investigation: conclusion of article: this study is unequivocally the largest single-center investigation in western india regarding therapeutic plasma exchange (tpe) in pediatric patients.It demonstrates that tpe by centrifugation is a safe procedure when physiological and technical challenges are effectively managed.Furthermore, distinct guidelines for apheresis in pediatric patients must be established, as their clinical disease trajectories and progression are markedly different from those of adults.Investigation is in process, a follow-up report will be provided.Citation: vijaykumar, s.C.(2025).Scope and safety of therapeutic plasma exchange by centrifugation in pediatric patients: experience at a tertiary care hospital in western india.Journal of population therapeutics & clinical pharmacology, 1496¿1501.Https://doi.Org/10.53555/2ta60r11.
Event or Problem Description
Per journal article ""scope and safety of therapeutic plasma exchange by centrifugation in pediatric patients: experience at a tertiary care hospital in western india"" by vijaykumar, s.C.(2025) abstract introduction therapeutic plasma exchange (tpe) is a well-known therapeutic modality for treating various pediatric diseases.However, no special guidelines are available for pediatric patients, and adult guidelines- american society for apheresis (asfa) are ollowed.Aim: to study the safety of tpe and analyze the various indications for which it can be done in pediatric patients.Material and methods: a 5-year retrospective analysis of the indications and their safety was done from 2018 to 2022.Tpe was done by centrifugation results: tpe was performed in 120 patients and 926 procedures were done.Antibody-mediated rejection (abmr) and atypical hemolytic uremic syndrome (a hus) were the most common indications with 42.5% of procedures each.Pre-renal transplant desensitization (8.3%) and wilsons disease (2.5%) were other indications.The most common adverse event seen was moderate (53.57%),and allergic reaction to replacement fluid -fresh frozen plasma (ffp) was the most common.Vomiting was the most common adverse event in the severe (42.85%) category and 3.57% of adverse events were mild.The most common indication where adverse events were seen was a hus followed by abmr.Conclusion: tpe by centrifugation is safe in pediatric patients however, a separate guideline for pediatric patients to categorize the indications is required.Adverse events were seen in 28 procedures out of 926 procedures (3.0%) according to the indications ffp was the replacement fluid in a hus & albumin was the replacement fluid in post-tx abmr mild: accounted to 3.57%.One 16-year-old male patient had nausea.Moderate adverse events: accounted to 53.57% age 8-17 years m: f 6 :3 most common was allergic reaction n= 9.Of these 9 procedures, 8 had fresh frozen plasma as replacement fluid for a hus and human albumin was in 1 for post-transplant abmr.Vomiting was the next most common adverse event,n=3(2 in a hus and 1 in pre tx-desensitization).Hypotension (n=2) was seen in a 14-year-old male and a 17-year-old female patient, both had undergone tpe for post tx abmr.The male patient also had poor flow in another procedure.Two patients who showed moderate adverse events, both developed one severe adverse event each severe: accounted to 42.85%.N=9 patients (m: f 7:2) seen in 12 procedures.One 7-year-old male patient undergoing tpe for a hus developed an allergic reaction(moderate) in his 1st procedure and developed hypertension (severe) during his second procedure.He underwent only 2 cycles of tpe another patient who had developed 2 moderate adverse events (hypotension and poor flow) developed chest pain in his 6th cycle.Ecg and spo2 were normal.Pulse was rapid 124/min.Vomiting n=2 was seen in abmr with albumin as replacement fluid.One patient, 8 yr male, developed rash where tpe was performed for ahus with ffp.One 5-year-old male patient became unconscious during his 13th cycle for ahus with ffp.Another 7-year-old female patient developed hypotension and was shifted to the critical care unit during her 7th cycle for ahus with ffp.One 5-year-old male patient developed convulsions during his 4th cycle for ahus.The patient was treated for the same and was stable later.One 12-year-old female patient became breathless after her 5th procedure for abmr with albumin all the adverse events were managed by the clinicians and there was no mortality because of tpe.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
Per journal article ""scope and safety of therapeutic plasma exchange by centrifugation in pediatric patients: experience at a tertiary care hospital in western india"" by vijaykumar, s.C.(2025) abstract introduction therapeutic plasma exchange (tpe) is a well-known therapeutic modality for treating various pediatric diseases.However, no special guidelines are available for pediatric patients, and adult guidelines- american society for apheresis (asfa) are ollowed.Aim: to study the safety of tpe and analyze the various indications for which it can be done in pediatric patients.Material and methods: a 5-year retrospective analysis of the indications and their safety was done from 2018 to 2022.Tpe was done by centrifugation results: tpe was performed in 120 patients and 926 procedures were done.Antibody-mediated rejection (abmr) and atypical hemolytic uremic syndrome (a hus) were the most common indications with (b)(4) of procedures each.Pre-renal transplant desensitization (8.3%) and wilsons disease ((b)(4)) were other indications.The most common adverse event seen was moderate ((b)(4)),and allergic reaction to replacement fluid -fresh frozen plasma (ffp) was the most common.Vomiting was the most common adverse event in the severe ((b)(4)) category and 3.57% of adverse events were mild.The most common indication where adverse events were seen was a hus followed by abmr.Conclusion: tpe by centrifugation is safe in pediatric patients however, a separate guideline for pediatric patients to categorize the indications is required.Adverse events were seen in 28 procedures out of 926 procedures (3.0%) according to the indications ffp was the replacement fluid in a hus & alb the age and gender of eight of the 120 patients was provided.However, due to the retrospective nature of the article, a request for further specific patient information is not feasible.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, g.1, h.6 and h.11.Investigation: conclusion of article: this study is unequivocally the largest single-center investigation in western india regarding therapeutic plasma exchange (tpe) in pediatric patients.It demonstrates that tpe by centrifugation is a safe procedure when physiological and technical challenges are effectively managed.Furthermore, distinct guidelines for apheresis in pediatric patients must be established, as their clinical disease trajectories and progression are markedly different from those of adults.Summary of terumo bct product in relation to the journal article:this study aims to analyze the various indications for therapeutic plasma exchange (tpe) and its safety in pediatric patients.It was a retrospective 5-year study conducted from january 2018 to december 2022.The study included patients of any gender under 18 years of age with conditions such as antibody-mediated rejection (abmr), atypical hemolytic uremic syndrome (ahus), pre-transplant desensitization, crescentic glomerulonephritis (gn), focal segmental glomerulosclerosis (fsgs), liver transplant rejection, etc.Adult patients and pediatric patients who did not opt for tpe were excluded.Analysis of indications was performed in patients referred to the department of transfusion medicine for tpe.Adverse events were classified into three categories according to the world association for apheresis (waa):1.    mild ¿ transient and not requiring intervention2.    moderate ¿ requiring medication or intervention3.    severe ¿ clinically unstable or requiring termination of the procedure tpe was performed using two types of continuous flow centrifugation machines available in the department: spectra optia and fresenius kabi com.Tec.Pre-procedure investigations, including complete blood count (cbc), serum creatinine, and serum electrolytes, were conducted.The procedure and its potential complications were explained to the patients or guardians.The patient¿s height, weight, hematocrit, temperature, pulse, respiratory rate, and blood pressure were recorded prior to the procedure after obtaining informed consent.A large-caliber vein, either the internal jugular vein or an arteriovenous fistula, was used for vascular access.Total blood volume was calculated using nadler¿s formula.In each patient, 1 to 1.5 times the plasma volume was exchanged.Fresh frozen plasma (ffp) or 20% human albumin was used as replacement fluid.The inlet flow rate was maintained at 45¿55 ml/min.The acid citrate dextrose (acd) ratio was kept between 1:12 and 1:14, depending on the replacement fluid used.Simultaneously, calcium gluconate (30 ml in 100 ml normal saline/dextrose solution) was infused throughout the procedure to prevent hypocalcemia.Injection avil (2 ml) was also added to prevent allergic reactions.A total of 120 patients (male:female = 84:36) underwent apheresis by centrifugation.Overall, 926 procedures were performed (mean 7.72 ± 10.34 per patient).The mean age was 11.1 ± 6.14 years, mean height was 130.77 ± 19.41 cm, and mean weight was 29.38 ± 13.31 kg.Of the 926 procedures, adverse events occurred in 28 procedures ((b)(4)).Regarding the terumo bct product, spectra optia, no specific information in the study attributed adverse reactions directly to procedures performed using this device.Tpe was performed for various indications, most commonly post-renal transplant abmr ((b)(4)) and atypical hus ((b)(4)%).Ffp was primarily used as replacement fluid in ahus cases, whereas albumin was used in post-transplant abmr.One patient experienced a mild adverse event, presenting with nausea.Fifteen patients experienced moderate adverse events.Among these, nine were allergic reactions; eight occurred in procedures using ffp for ahus, and one occurred with albumin in post-transplant abmr.Vomiting was the next most common event (n = 3; two in ahus and one in pre-transplant desensitization).Hypotension (n = 2) was observed in a 14-year-old male and a 17-year-old female, both undergoing tpe for post-transplant abmr.One male patient also experienced poor flow in another procedure.Two patients with moderate adverse events subsequently developed one severe adverse event each.Severe events were documented in nine patients across 12 procedures.A 7-year-old male with ahus developed an allergic reaction (moderate) during his first procedure and hypertension (severe) during his second procedure; he underwent only two cycles of tpe.Another patient who had developed moderate adverse events (hypotension and poor flow) later experienced chest pain during the sixth cycle; however, this was likely anxiety-related, as all investigations were normal.Vomiting (n = 2) was observed in abmr cases with albumin replacement.One 8-year-old male developed a rash during tpe for ahus with ffp.A 5-year-old male became unconscious during his 13th cycle for ahus with ffp and was managed by pediatric nephrologists.A 7-year-old female developed hypotension during her 7th cycle and was transferred to the critical care unit.Another 5-year-old male developed convulsions during his 4th cycle, which were effectively treated with diazepam, and he subsequently stabilized.A 12-year-old female developed breathlessness after her 5th procedure for abmr with albumin; she improved with nasal oxygen and propped-up positioning.All adverse events were managed successfully, and no mortality was attributed to tpe.Technical errors in the machines were reported in three procedures; however, no further details were provided.The authors noted that as these errors accounted for only 10% of adverse events, the machines were considered reliable.The authors concluded that tpe by centrifugation is a safe procedure when physiological and technical challenges are appropriately managed.Furthermore, specific guidelines for apheresis in pediatric patients are required, as their disease progression and clinical profiles differ significantly from those of adults.Tpe can be challenging in pediatric patients due to smaller blood volume, limited vascular access, and differing disease patterns compared to adults.The most common adverse events were moderate in severity, with allergic reactions to ffp being the most frequent.Since this was a case study involving pediatric patients between january 2018 ¿ december 2022, lot numbers were not requested; therefore, a disposables lot history search could not be conducted for this specific incident.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.In relation to the pruritus, allergic reactions are usually associated with replacement regimens that include blood components, but they can also be caused by medications, hydroxyethyl starch, or sterilization of disposable tubing with ethylene oxide.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.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.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.  since this was a retrospective study reviewing patients that received tpe between january 2018 to december 2022; 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 the aabb circular of information for the use of human blood components (revised 2017), allergic reactions frequently occur (ie, 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually respond to antihistamines.More severe manifestations, including respiratory and cardiovascular symptoms, are more consistent with anaphylactoid/anaphylactic reactions and may require more aggressive therapy (see below).No laboratory procedures are available to predict these reactions.  anaphylactic reactions, characterized by hypotension, tachycardia, nausea, vomiting and/or diarrhea, abdominal pain, severe dyspnea, pulmonary and/or laryngeal edema, and bronchospasm and/or laryngospasm, are rare (<10/100,000 transfused units) but dangerous complications requiring immediate treatment with epinephrine.While these reactions have been reported in iga-deficient patients with anti-iga antibodies and patients with haptoglobin deficiency, most reactions are idiosyncratic and not associated with a specific serum protein deficiency, polymorphism, or identifiable cause (see attachment, 2017 aabb circular page 6 in content tab).  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.In relation to the pruritus, allergic reactions are usually associated with replacement regimens that include blood components, but they can also be caused by medications, hydroxyethyl starch, or sterilization of disposable tubing with ethylene oxide.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected   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.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions   investigation is in process, a follow-up report will be provided.  citation: vijaykumar, s.C.(2025).Scope and safety of therapeutic plasma exchange by centrifugation in pediatric patients: experience at a tertiary care hospital in western india.Journal of population therapeutics & clinical pharmacology, 1496¿1501.Https://doi.Org/10.53555/2ta60r11.

• Brand Name: Spectra Optia
• Common Device Name: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): Terumo BCT; lakewood CO 80215
• Manufacturer (Section G): Terumo BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: kristi edgington ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 23924032
• Report Number: 1722028-2025-00286
• Device Sequence Number: 9030175
• Product Code: LKN
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4102201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 05/14/2026; 08/21/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 05/18/2026; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Male