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

Catalog Number	10310
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Numbness (2415)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation: per the conclusion of the article "shorter procedure was the main predictor for effective tg clearance.This can be achieved by continuous apheresis technology, particularly when using albumin as rf.Tg removal via optia seems to be optimized by using heparin." investigation is in process, a follow-up report will be provided.Citation: hussein, e.A.(2024).Factors affecting clinical outcomes of continuous and intermittent plasmapheresis in patients with severe hypertriglyceridemia. therapeutic apheresis and dialysis. https://doi.Org/10.1111/1744-9987.14134.
Event or Problem Description
Per journal article "factors affecting clinical outcomes of continuous and intermittent plasmapheresis in patients with severe hypertriglyceridemia" by eiman a.Hussein patients were observed for severe and mild adverse events (aes).Aes were considered severe if patients required admission to the icu.They were categorized as follows: 1.Citrate related which included tingling, numbness, nausea, vomiting, abdominal and chest pains.2.Hypotension which was treated by saline infusion.3.Plasma related.4.Venous access related.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: per the conclusion of the article "shorter procedure was the main predictor for effective tg clearance.This can be achieved by continuous apheresis technology, particularly when using albumin as rf.Tg removal via optia seems to be optimized by using heparin." medical intervention beyond first aid cannot be confirmed.Overview: an investigation was conducted for journal article that references terumo bct product.Journal article, titled ¿factors affecting clinical outcomes of continuous and intermittent plasmapheresis in patients with severe hypertriglyceridemia¿ by hussein et al.2024, was reviewed with primary purpose of screening for allegations of terumo bct device causing or contributing to death/injury or device malfunctions.Evaluation returned part or photograph: 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.Investigation details: the purpose of the journal article study is noted in the article abstract: abstract introduction: acute hypertriglyceridemia is considered a category iii indication for plasmapheresis.The use of plasma as replacement fluid (rf) has been suggested to replace the consumed lipoprotein lipase.Heparin when used as an anticoagulant could possibly release lipoprotein lipase, thereby increasing triglyceride clearance.Methods: the impact of rf (albumin vs fresh frozen plasma (ffp) and anticoagulant (acd-a vs.Heparin) on triglycerides following plasmapheresis in 27 patients with severe hypertriglyceridemia (shtg) was investigated.A paired study of four patients with recurrent shtg was conducted, evaluating continuous (optia) versus intermittent flow plasmapheresis (haemonetics).Results: shorter procedures positively impacted triglycerides (tg) drop postsessions p < 0.05.In albumin sessions, patients who used heparin demonstrated significantly greater drop in tg and required less sessions than did those with citrate p < 0.05.In heparin sessions, patients who used albumin demonstrated significantly greater drop in triglycerides and required less sessions than did those with ffp p < 0.05.Three of six patients who used ffp and heparin showed a triglyceride drop of 11.7% following three sessions and a 50% drop with one albumin session.Compared with haemonetics, optia removed comparable volumes of plasma in less time, processing smaller blood volumes and using less citrate p < 0.05.Patients demonstrated significantly lower drop in tg and required more sessions with haemonetics than they did with optia p < 0.05.Conclusion: shorter procedure was the main predictor for effective tg clearance.This can be achieved by continuous apheresis technology, particularly when using albumin as rf.Tg removal via optia seems to be optimized by using heparin.The authors aimed to investigate the impact of replacement fluid (albumin vs.Fresh frozen plasma (ffp)) and the anticoagulant (heparin vs.Acd-a) on the clinical efficacy of plasmapheresis.They studied patients with acute and recurrent shtg and evaluated factors that might influence tg levels post sessions.Another objective was to explore the role of the apheresis device (continuous vs.Intermittent flow centrifugation) as a possible determinant of tg reduction post sessions.27 patients with 1550 31 episodes of shtg, with tg levels of 7800 mg/dl.Of the 27 patients enrolled in this study, 24 (88.9%) were females.Their ages ranged from 17 to 65 years with a median of 20 years.All patients had chronic abdominal pain.Four patients presented with acute pancreatitis (15%) and four had cardiovascular disease (15%).Sessions of 21patients were performed with albumin as the rf (group 1).Acd-a was used as the anticoagulant in 11 episodes (group ia) while heparin was used in 10 episodes (group i b).Heparin was used as the anticoagulant in patients with very high tg values (>3000 mg/dl), based on the judgment of the attending physician.Six patients underwent sessions with ffp because of their impaired coagulation and all patients used heparin as the anticoagulant (group 2).The authors increased the hematocrit sitting by 3% in patients with tg levels over 2000 mg/dl, who underwent sessions on the optia.Regarding terumo bct product, optia, a series of main adverse events were reported as a percentage of total adverse events.Adverse events were considered severe if patients required admission to the icu.These included citrate related reactions, which included tingling, numbness, nausea, vomiting, abdominal and chest pains.Hypotension which was treated by saline infusion.Plasma related which was rapidly alleviated by diphenhydramine, and venous access related.The authors concluded that observing significant performance superiority of optia, when compared with the mcs.Optia collected equivalent volumes of plasma, in less time, while processing smaller blood volumes (p < 0.05).It also demonstrated a significant drop of tg levels per session (53.3%), as compared with mcs (24%) (p < 0.05).This finding resulted in significantly fewer sessions with optia, when compared with mcs (p < 0.05).Since this was a journal publication to understand the impact of the replacement fluid (albumin vs.Ffp) and anticoagulant (heparin vs.Acd-a) on clinical outcomes of patients with shtg undergoing plasmapheresis between from january 2011 to january 2023, 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.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.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.Root cause: a root cause assessment was performed for the reported citrate reactions.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.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.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.Therefore a definitive root cause for the hypocalcemia reported could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.The reported hypotension is a common side effects of therapeutic apheresis procedures.They are typically caused by the patient's disease state, the rate of ac infusion, fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.A root cause assessment was performed for venous access related issues experienced by the authors.A definitive root cause cannot be determined, however possibles causes include, but are not limited to: ¿ poor phlebotomy technique ¿ anatomical variations ¿ vein condition (scarring/collapse/sclerosis) ¿ vascular disease ¿ improper catheter size and/or insertion techniques ¿ vasospasm or clotting within the catheter ¿ improper blood flow rates citation: hussein, e.A.(2024).Factors affecting clinical outcomes of continuous and intermittent plasmapheresis in patients with severe hypertriglyceridemia.Therapeutic apheresis and dialysis.Https://doi.Org/10.1111/1744-9987.14134.
Event or Problem Description
Per journal article "factors affecting clinical outcomes of continuous and intermittent plasmapheresis in patients with severe hypertriglyceridemia" by eiman a.Hussein patients were observed for severe and mild adverse events (aes).Aes were considered severe if patients required admission to the icu.They were categorized as follows: 1.Citrate related which included tingling, numbness, nausea, vomiting, abdominal and chest pains.2.Hypotension which was treated by saline infusion.3.Plasma related.4.Venous access related.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.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL 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: 19425231
• Report Number: 1722028-2024-00198
• Device Sequence Number: 15458417
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10310
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 12/21/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 12/27/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown