MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number	10220
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Syncope/Fainting (4411)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Luzzi, j.R., borba, c.C., miyaji, s.C., brito, c.A., navarro-xavier, r., & dinardo, c.L.(2021).Reduced volume of red blood cell priming is safe for pediatric patients undergoing therapeutic plasma exchange.Transfusion and apheresis science, 60(1), 103005.Https://doi.Org/10.1016/j.Transci.2020.103005.
Event or Problem Description
Per journal article, "reduced volume of red blood cell priming is safe for pediatric patients undergoing therapeutic plasma exchange", by "luzzi, j.R., borba, c.C., miyaji, s.C., brito, c.A., navarro-xavier, r., & dinardo, c.L.", therapeutic plasma exchange (tpe) procedures in pediatric patients are challenging due to the large extracorporeal volume of the cell separators, which were designed for adults.Red blood cell (rbc) priming is an alternative for overpassing the risks of hypovolemia, but data referring to the volume of packed rbcs to be infused are yet incomplete.Restricting the volume of rbc priming may potentially be associated with less transfusion reactions.To determine the safety of administering a reduced volume of rbc priming for pediatric patients undergoing tpe, in comparison to the standard volume recommended by the cell separators manufacturers.This was a case-control study which enrolled 15 pediatric patients undergoing tpe and weighting more than 10kg.The tpe procedures (n = 406) were divided in two groups: 1) group1: tpe with 150 ml of packed rbc priming and 2) group2: tpe with 150-250 ml of rbc priming.Groups were compared in terms of hemoglobin / hematocrit and occurrence of adverse reactions.Group1 and group2 did not differ significantly in relation to pre- and post-tpe hemoglobin (hb) levels (p = 0.19 and p = 0.18, respectively).The hb (hb pre-tpe hb post-tpe) was also not statistically different between the groups.The number of adverse reactions was significantly higher in group 2 in relation to group 1 (p = 0.01).The number of allergic reactions was also higher in group 2 (p = 0.06).Restricting the volume of rbc priming to less than 150 ml is safe for pediatric patients weighting more than 10kg and associated with lower rates of transfusion-related adverse reactions.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 platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11 and corrected information in d.1.Investigation: since this was a journal publication outlining a retrospective study on patients undergoing tpe procedures between january 2012 and january 2019 using the spectra optia apheresis system, the disposable 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.Since this was a journal publication outlining a retrospective study on patients undergoing tpe procedures between january 2012 and january 2019 using the spectra optia apheresis system, the disposable 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.Summary of terumo bct product in relation to the journal article: therapeutic plasma exchange (tpe) procedures in pediatric patients are associated with significantly higher rates of adverse reactions in comparison to adults.Packed red blood cell (rbc) priming should be considered if the estimated ecv exceeds 10-15% of the patient¿s tbv.Most commonly, the estimated ecv, which is provided by the machine¿s manufacturer, is transfused as priming.However, this estimated ecv may result in an excessive rbc priming, potentially associated with transfusion reactions and with a high final amount of fluid returning to the patients (rinseback volume).The infusion of packed rbcs as priming may be associated with transfusion adverse reactions.The transfusion-related adverse events vary in severity and may pose as a challenge in cases of multiple episodes.This was a retrospective case-controlled studied which took place at the hemotherapy and hematology unit of samaritano, s¿ao paulo, brazil.All patients undergoing tpe procedures and presenting the following inclusion criteria were included: 1) tpe performed between january 2012 and january 2019 using the spectra optia apheresis system (terumo bct, lakewood, colorado, usa); 2) body weight varying from 10 to 23kg.The last criteria was based on the fact that children weighting less than 23kg would be at risk of adverse reactions because the expected extracorporeal volume (approximately 186 ml) would exceed 10% of the total body volume; 3) indication of rbc priming before the tpe procedure using packed rbcs stored in sag-mannitol.Patients were excluded if the body weight was less than 10kg, if rbc priming was not indicated before tpe or if critically ill (in intensive care unit).The study was conducted according to the helsinki principles and approved by the local ethical committee (comissao nacional etica pesquisa ¿ brazil).Tpe was performed in the spectra optia apheresis system following the manufacturer¿s instructions.In all cases, rinseback was performed.The tpe procedures were organized in two groups: group1: rbc priming performed with =150 ml of packed rbcs group2: rbc priming performed with 150-200 ml of packed rbcs fifteen paediatric patients were included in the study, who underwent 406 therapeutic plasma exchange (tpe) procedures.The mean age of the included patients was 5.07, varying from 1 to 10 years old (table 1).Humoral rejection of kidney transplant was the most common diagnosis (46.6%) (table 1).Rbc priming was performed in all tpe procedures, with different volumes: 236 (58.1%) with =150 ml of rbcs, 109 (26.9%) with 150- 250 ml of rbcs and 61 (15%) with =250 ml of rbcs.The group of patients receiving more than 250 ml of rbc priming were excluded from the analysis, since tpe was performed in a different system (cobe spectra apheresis system).Regarding terumo bct product, spectra optia, multiple adverse reactions were documented within the retrospective study.These included vasovagal reactions, allergic reactions, high blood pressure and hypocalcemia.The authors concluded that the incidence of adverse reactions was higher in the group receiving standard rbc priming in comparison to the group receiving reduced rbc priming, mostly due to allergic reactions that may be related to the transfusion.It was concluded that the results show that administering less than 150 ml of packed rbcs as priming for patients weighting between 11kg and 18kg is not associated with increased risk of hypotension or anaemia.In fact, restricting the volume of rbc priming was associated with less allergic reactions, possibly reflecting a decrease in the occurrence of adverse reactions to the transfused rbcs.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.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, miscellaneous reactions such as delayed complications of apheresis include hemorrhage, thrombosis, infection related to access lines or blood components, anemia, and protein depletion.Therapeutic apheresis procedures may lead to major physiologic changes, including hypocalcemia caused by citrate infusion, hemodynamic changes associated with fluid shifts, and depletion of cellular and plasma constituents.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.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.Root cause: a root cause assessment for the adverse patient reactions was performed for this complaint.The reported adverse events (hypertension/vasovagal) are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, donor's sensitivity to the procedure and/or hemodynamic stress of the procedure a root cause assessment was performed for the drop in ionized calcium.A decreased ionized calcium in circulation is a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, the citrate contents in the replacement fluid, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.These reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, the citrate contents in the replacement fluid, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.A definitive root cause of the allergic reactions could not be determined.Possible reasons for reactions related to transfusion of platelet concentrates include (i) ige and igg antibodies in the recipient against plasma proteins in the transfused blood component, (ii) transfusion of cytokines, chemokines, and histamine generated in the platelet product during preparation and storage.The best-known type of anaphylactic reaction is induced by iga deficiency of the recipient and subsequent formation of anti-iga.Patients lacking only one iga subclass may form subclass-specific anti-iga; other patients may get immunized against allotypes on the iga molecules.Patients with such antibodies of ¿limited specificity¿ usually experience less severe anaphylactic reactions than patients with complete iga deficiency and class-specific anti-iga.Other possible causes for the allergic reactions include but are not limited to: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.* hypersensitivity to the components inside the disposable set.Citation: luzzi, j.R., borba, c.C., miyaji, s.C., brito, c.A., navarro-xavier, r., & dinardo, c.L.(2021).Reduced volume of red blood cell priming is safe for pediatric patients undergoing therapeutic plasma exchange.Transfusion and apheresis science, 60(1), 103005.Https://doi.Org/10.1016/j.Transci.2020.103005.
Event or Problem Description
Per journal article, "reduced volume of red blood cell priming is safe for pediatric patients undergoing therapeutic plasma exchange", by "luzzi, j.R., borba, c.C., miyaji, s.C., brito, c.A., navarro-xavier, r., & dinardo, c.L.", therapeutic plasma exchange (tpe) procedures in pediatric patients are challenging due to the large extracorporeal volume of the cell separators, which were designed for adults.Red blood cell (rbc) priming is an alternative for overpassing the risks of hypovolemia, but data referring to the volume of packed rbcs to be infused are yet incomplete.Restricting the volume of rbc priming may potentially be associated with less transfusion reactions.To determine the safety of administering a reduced volume of rbc priming for pediatric patients undergoing tpe, in comparison to the standard volume recommended by the cell separators¿ manufacturers.This was a case-control study which enrolled 15 pediatric patients undergoing tpe and weighting more than 10kg.The tpe procedures (n = 406) were divided in two groups: 1) group1: tpe with =150 ml of packed rbc priming and 2) group2: tpe with 150-250 ml of rbc priming.Groups were compared in terms of hemoglobin / hematocrit and occurrence of adverse reactions.Group1 and group2 did not differ significantly in relation to pre- and post-tpe hemoglobin (hb) levels (p = 0.19 and p = 0.18, respectively).The ¿ hb (hb pre-tpe ¿ hb post-tpe) was also not statistically different between the groups.The number of adverse reactions was significantly higher in group 2 in relation to group 1 (p = 0.01).The number of allergic reactions was also higher in group 2 (p = 0.06).Restricting the volume of rbc priming to less than 150 ml is safe for pediatric patients weighting more than 10kg and associated with lower rates of transfusion-related adverse reactions.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.Since this was a journal publication outlining a retrospective study on patients undergoing tpe procedures between january 2012 and january 2019 using the spectra optia apheresis system, a request for specific patient information is not feasible.The platelet collection set is not available for return because it was discarded by the customer.

• 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: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 19961773
• Report Number: 1722028-2024-00336
• Device Sequence Number: 7064851
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 02/13/2025
• 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 Sex: Unknown