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

Catalog Number 10220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rash (2033); Tachycardia (2095)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Citation: jang, s.M., bahjri, k., lee, j., nabavi, s., abdipour, a.Use of angiotensin converting enzyme inhibitors in patients receiving therapeutic plasma exchange with a centrifuge-based apheresis system.Therapeutic apheresis and dialysis.2020.Investigation is in process.A follow-up report will be provided.

Event Description

According to the article, "use of angiotensin converting enzyme inhibitors in patients receiving therapeutic plasma exchange with a centrifuge-based apheresis system", a retrospective chart review was done on patients = (b)(6) yrs old.All patients had a range of 1.0-1.2 plasma volume exchange.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.Only adverse drug reactions (hypotension, tachycardia pruritus/rash/hives, flushing, nasal congestion, throat irritation) were reported.Rates of adverse drug events (duplicated from jang et al, table 3).Data is stratified by patients who used ace inhibitors and those who did not.Acei use yes (n=57) no (n=195) p-value pruritus/rash/hives 2 (3.5%) 10 (5.1%) 0.5a flushing 1 (1.8%) 1 (0.5%) 0.4a nasal congestion 1 (1.8%) 3 (1.5%) 0.6a low blood pressure 32 (56.1%) 119 (61%) 0.5b tachycardia 12 (21.1%) 33 (16.9%) 0.5b a chi-square test b fisher¿s exact test angiotensin converting enzyme inhibitor = acei.Specific details for these events, such as patient information and medical intervention necessary, were not included in the article, therefore this report is being provided as a summary of the events.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: per the article, "patient demographics [age, sex, race (caucasian, african american, hispanic, asian, and others), height, weight, body mass index (bmi)], acei use, clinical manifestations of adr (hypotension, tachycardia pruritus/rash/hives, flushing, nasal congestion, throat irritation) and tpe prescription (treatment duration, blood flow rate, type of replacement fluid, replacement fluid flow rate and fluid balance) data were collected from the emr.Hypotension is defined as drop in systolic blood pressure more than 20 mm hg or systolic blood pressure decline to less than 100 mm hg during the treatment or significant and symptomatic drop in blood pressure requiring nurse or physician intervention.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).If patients received multiple tpe treatments between 2014 and 2019, the first treatment within this period was used for a data collection.Binary logistic regression was used to assess the association of acei with aes after adjusting for type of fluid replacement.Types of adverse drug reactions (table 3): acei use: yes (n=57) no (n=195) pruritus/rash/hives 2 (3.5%) 10 (5.1%) flushing 1 (1.8%) 1 (0.5%) nasal congestion 1 (1.8%) 3 (1.5%) low blood pressure 32 (56.1%) 119 (61%) tachycardia 12 (21.1%) 33(16.9%) 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 (table 1).The majority (79%) of patients used albumin as a replacement fluid during tpe with centrifugation.More than a half (68%) of patients who were taking acei compared to patients who were not taking acei after adjusting for the types of replacement fluids (table 2).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%).Current clinical practice of withholding acei per outdated literature may lead to unwanted patient outcomes such as an uncontrolled hypertension, and medication or dosage change.Switching to angiotensin receptor blocker, such as losartan, may be an option.Yet, losartan has been shown to increase bradykinin level without significant hypotension and aes during lipid apheresis.In the study, some patients continued to take acei and completed the treatment course without any significant aes.On the other hand, some patients who were not on acei showed signs of possible aes.Hypotension and tachycardia were the most common symptoms for aes.Mild hypotension has been observed in elderly patients and with saline use as a replacement fluid.Our center does not use saline at all as a replacement fluid.We believe hemodynamic change during tpe is the cause of transient hypotension and tachycardia; lack of statistically significant differences between the two groups supports our conclusion.We adjusted our data for types of replacement fluid (albumin vs ffp) and did not find any significant differences in both groups.We have further adjusted for hypotension to see if any other symptoms might have been higher in acei group, but no significant difference was found." the authors concluded 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 angi otensin-converting enzyme inhibitors is not associated with increased risk of adverse events in patients receiving therapeutic plasma exchange with centrifugation.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.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.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.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.

Event Description

This was a retrospective study of 252 patients between 2014 and 2019.A request for specific patient information is not feasible.The authors stated 131 of the patients were male, 121 were female; patients were between 28-64 years old, and the weight range was 57- 110 kg.The retrospective review studied 252 patients age =18 (52% male) who received tpe treatments between 2014 and 2019.Pregnant patients were excluded.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: the specific root cause for the adverse reactions could not be determined.Possible causes for citrate reactions/tachycardia include but are not limited to ac management during the procedure, hemodynamic change, patient disease state, and/or patient sensitivity to anticoagulant.Possible causes for allergic reactions( pruritis / rash / hives / flushing / nasal congestion ) include but are not limited to replacement fluid, concurrent medications, or ethylene oxide from sterilization processes.Possible causes for hypotension reactions include but are not limited to hemodynamic change, patient disease state, and/or patient sensitivity to the procedure.

Manufacturer Narrative

This report is being filed to provide addtional information in d4.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11108650
• MDR Text Key: 225252450
• Report Number: 1722028-2021-00001
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other