MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA TPE SET

Catalog Number	70500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Rash (2033)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Overview: an investigation was conducted for journal article that references terumo bct product.Journal article, titled ¿use of angiotensin converting enzyme inhibitors in patients receiving therapeutic plasma exchange with a centrifuge-based apheresis system¿ by abdipour et al.Sept 2020, was reviewed with primary purpose of screening for allegations of terumo bct device causing or contributing to death/injury or device malfunctions.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.Summary of terumo bct product in relation to the journal article: regarding terumo bct product, optia, the authors noted that hypotension (88.3%), tachycardia (26.3%), and throat irritation (4.1%) were the most common signs of adverse events, but also documented flushing, hypocalcemia, nasal congestion and pruritus/rash & hives as types of drug adverse reactions.This is a retrospective chart review study at loma linda university health from 01/2014 to 01/2019.Subjects were screened with international classification of diseases 9/10 codes for the tpe in the electronic medical record (emr).Centrifuge-based apheresis system, spectra optia (terumo bct, lakewood, co, usa) was used for majority of tpe treatments.Some patients received tpe using cobe spectra apheresis system (terumo bct).All patients had a range of 1.0-1.2 plasma volume exchange (pve).All patients were treated with 100% fluid balance, and citrate dextrose solution a was used as an anticoagulant agent.Calcium gluconate 400 mg for every 500 ml of plasma process was given to the patients.If patients experienced severe hypocalcemia symptoms, 1 g of calcium gluconate was administered as needed per protocol.Inclusion criteria were patients age =18 who received tpe treatments within the study period.Three types of replacement fluid were used: fresh frozen plasma (ffp), albumin, or ffp + albumin.Acei uses were categorized into two categories: (a) patients on acei; and (b) patients never on acei.The diagnosis for our patients for tpe includes myasthenia gravis, chronic inflammatory demyelinating polyradiculoneuropathy, thrombotic thrombocytopenic purpura, and organ transplant rejection (heart, liver, and kidney).Total of 252 patients were included in this study.The majority of patients (n = 195) were not taking acei at least 24 hours prior to their tpe treatment with centrifugation.The other patients were still taking acei during their course of tpe treatment over a few weeks.No significant demographic difference was observed between patients who developed ae vs patients with no ae during centrifuge-based tpe the majority (79%) of patients used albumin as a replacement fluid during tpe with centrifugation.More than a half (68%) of patients showed at least one of the signs and symptoms of aes.No significant difference was observed between patients who were taking acei compared to patients who were not taking acei after adjusting for the types of replacement fluids we further made adjustments for hypotension and still did not find a statistical difference between these two groups (patients taking acei vs no acei).Age, gender, race, bmi, and duration of centrifuge-based tpe did not influence whether patients had adr during treatment or not.Table 3 represents the most common signs and symptoms, which were hypotension (88.3%), tachycardia (26.3%), and throat irritation (4.1%).The authors concluded that hypotension, pruritus, and rash were common adverse events during therapeutic plasma exchange with a centrifuge-based device.There were no severe adverse events in our subjects in the study.The present findings suggest that the use of angiotensin-converting enzyme inhibitors is not associated with increased risk of adverse events in patients receiving therapeutic plasma exchange with centrifugation.Since this was a journal publication to assess the use of angiotensin converting enzyme inhibitors in patients receiving therapeutic plasma exchange from 01/2014 to 01/2019, 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.Since this was a retrospective chart review study at loma linda university health from 01/2014 to 01/2019 using therapeutic plasma exchange (tpe) performed on either the spectra optia or the cobe spectra platforms, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.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.Symptoms of allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv root cause: a root cause assessment was performed for the adverse reactions.The reported adverse reactions are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.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.Possible causes for the allergic reactions include but are not limited to an allergy to replacement solution and/or patient sensitivity to eto.Citation: jang, s.M., bahjri, k., lee, j., nabavi, s., & abdipour, a.(2020).Use of angiotensin converting enzyme inhibitors in patients receiving therapeutic plasma exchange with a centrifuge-based apheresis system.Therapeutic apheresis and dialysis, 25(4), 497¿501.Https://doi.Org/10.1111/1744-9987.13589.
Event or Problem Description
Per journal article "use of angiotensin converting enzyme inhibitors in patients receiving therapeutic plasma exchange with a centrifuge-based apheresis system" by jang, s.M., bahjri, k., lee, j., nabavi, s., abdipour, a.Angiotensin-converting enzyme inhibitors (acei) are frequently used antihypertensive medications with additional advantages such as reducing proteinuria and cardiovascular events.Acei are commonly held at least 24 hours before a therapeutic plasma exchange (tpe) to reduce possibility of adverse events (aes) including adverse drug reactions (adr).The objective of this study was to determine if acei use increases the risk of adr in patients receiving tpe with a conventional centrifuge-based apheresis system.This is a retrospective chart review study (n = 252; 52% male).Binary logistic regression was used to analyze the association of acei use and aes.Of 171 patients who had ae during tpe, only 38 patients were taking acei.There was no significant association between acei use and aes after adjustments (odds ratio = 0.885, 95% confidence interval: 0.468, 1.674).Our results suggest that risk of aes is not higher in patients taking acei receiving tpe using a centrifuge-based machine.Randomized controlled prospective trials may be needed to further investigate this matter.The collection set is not available for return because it was discarded by the customer.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.

• Brand Name: COBE SPECTRA
• Common Device Name: COBE SPECTRA TPE 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: 21027493
• Report Number: 1722028-2024-00574
• Device Sequence Number: 8995112
• Product Code: LKN
• UDI-Device Identifier: 05020583705005
• UDI-Public: 05020583705005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK080035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: 70500
• 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: 12/12/2024
• Initial 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: Other; Required Intervention
• Patient Sex: Unknown