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	Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article, "therapeutic plasma exchange in neuromyelitis optica spectrum disorders and related disorders in resource-limited settings: outcomes in a multiethnic single-center population" by ong, z.M., schee, j.P., & viswanathan, s.(2019), therapeutic plasma exchange (tpe) efficiency in treatment of a single relapse in steroid refractory patients with neuromyelitis optica spectrum disorders (nmosd) in a multi-ethnic resource-limited setting was evaluated.This was a historical cohort study on the clinical outcomes post-tpe in a multiethnic cohort of 53 steroid-refractory nmosd patients at a single malaysian tertiary center.Primary outcomes, assessed both pre- and post-tpe, were medical research council scale of muscle power, modified rankin scale, expanded disability status scale (edss), and visual acuity.Secondary outcomes were ambulatory status and target neurological deficit (tnd)-based tpe response.Significant improvements in medical research council, modified rankin scale, edss, and visual acuity (p ¿¿¿ 0.001) were observed at 1-month post-tpe with further improvement of edss at 6 months (edss¿¿6) post-tpe (p = 0.001).At 6 months post-tpe, 87% of patients has successful tnd-based tpe response and 69.8% were ambulating without support.Patients with anti-aquaporin 4 seronegativity (p = 0.004), myelitis and brainstem features at first relapse (p = 0.004), longer cord lesions (p = 0.030), higher pre-tpe edss of ¿¿¿8 (p = 0.018) and delayed tpe initiation of ¿¿¿14 days (p = 0.047) were significantly associated with improved edss6.Tnd-based tpe response was significant in absence of cord atrophy (p = 0.030).Tpe is an effective treatment for steroid-refractory acute relapses of nmosd in a multiethnic malaysian population despite its resource-limited setting.The predictive factors of edss¿¿6 improvement were anti-aquaporin 4 seronegativity, longer cord lesions, and higher pre-tpe edss.Absence of cord atrophy was predictive of better tnd-based tpe response.Unexpectedly, our study showed that delayed tpe initiation of more than 14 days and up to 60 days may also be beneficial.Per the journal article, all patients recovered completely with appropriate treatment.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.The collection set is not available for return because it was discarded by the customer.
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.Ong, z.M., schee, j.P., & viswanathan, s.(2019).Therapeutic plasma exchange in neuromyelitis optica spectrum disorders and related disorders in resource¿¿¿limited settings: outcomes in a multiethnic single¿¿¿center population.Therapeutic apheresis and dialysis, 24(3), 312¿¿¿323.Https://doi.Org/10.1111/1744-9987.13446.
Event or Problem Description
Per journal article, "therapeutic plasma exchange in neuromyelitis optica spectrum disorders and related disorders in resource-limited settings: outcomes in a multiethnic single-center population" by ong, z.M., schee, j.P., & viswanathan, s.(2019), therapeutic plasma exchange (tpe) efficiency in treatment of a single relapse in steroid refractory patients with neuromyelitis optica spectrum disorders (nmosd) in a multi-ethnic resource-limited setting was evaluated.This was a historical cohort study on the clinical outcomes post-tpe in a multiethnic cohort of 53 steroid-refractory nmosd patients at a single malaysian tertiary center.Primary outcomes, assessed both pre- and post-tpe, were medical research council scale of muscle power, modified rankin scale, expanded disability status scale (edss), and visual acuity.Secondary outcomes were ambulatory status and target neurological deficit (tnd)-based tpe response.Significant improvements in medical research council, modified rankin scale, edss, and visual acuity (p < 0.001) were observed at 1-month post-tpe with further improvement of edss at 6 months (edss¿6) post-tpe (p = 0.001).At 6 months post-tpe, 87% of patients has successful tnd-based tpe response and 69.8% were ambulating without support.Patients with anti-aquaporin 4 seronegativity (p = 0.004), myelitis and brainstem features at first relapse (p = 0.004), longer cord lesions (p = 0.030), higher pre-tpe edss of =8 (p = 0.018) and delayed tpe initiation of >14 days (p = 0.047) were significantly associated with improved edss6.Tnd-based tpe response was significant in absence of cord atrophy (p = 0.030).Tpe is an effective treatment for steroid-refractory acute relapses of nmosd in a multiethnic malaysian population despite its resource-limited setting.The predictive factors of edss¿6 improvement were anti-aquaporin 4 seronegativity, longer cord lesions, and higher pre-tpe edss.Absence of cord atrophy was predictive of better tnd-based tpe response.Unexpectedly, our study showed that delayed tpe initiation of more than 14 days and up to 60 days may also be beneficial.Per the journal article, all patients recovered completely with appropriate treatment.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.This was a journal publication to evaluate therapeutic plasma exchange (tpe) efficiency in treatment of a single relapse in steroid refractory patients with neuromyelitis optica spectrum disorders (nmosd) in a multi-ethnic resource-limited setting from an existing pool of nmosd patients attending the neurology clinic at kuala lumpur hospital from january 2005 to september 2018.A request for specific patient information is not feasible.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 and corrected information in e.1.Investigation: summary of terumo bct product in relation to the journal article: treatment protocol: all nmosd patients presenting with an acute relapse without features of infections were treated with intravenous methylprednisolone (ivmp) 1 g daily for the first 5 days followed by a tapering dose of oral prednisolone.Oral prednisolone was continued post-ivmp at the dose of 1 mg/kg for 1 month then tapered down every 2 weeks to a maintenance dose of 10¿20 mg daily.Oral prednisolone was given for a total of 2 years post-relapse and an immunosuppressant was given for 5 years post-relapse.Steroid-refractory acute relapse was defined by no improvement or suboptimal response (i.E.No or less than 50% improvement in visual acuity and power on mrc) to ivmp upon completion of a 5-day course within the first week of treatment assessed daily.However, if worsening of the clinical condition was observed upon daily assessment during the course of ivmp, tpe would be initiated earlier.Upon tpe initiation, each patient undergoes five exchange sessions of tpe on alternate days.Each session involves 1¿2 l of total plasma exchanged for 1¿2 l of 5% albumin.The technique is explained further in section 2.3.Early tpe was defined as tpe initiated at 14 days or less from onset of acute relapse while late tpe was tpe initiated later than 14 days.Clinical condition was assessed through the various outcome measures as detailed in section 2.4.All patients underwent rehabilitation after tpe and continued to receive rehabilitation therapy at 6 months post-tpe.Tpe technique: informed consent was received from every patient prior to commencing therapy.Tpe procedures were performed by a dedicated tpe team, which included experienced staff nurses, specialists and consultant neurologists.Prior to 2015, membrane ultrafiltration methods utilizing renal replacement machines in the nephrology department were used for tpe therapy.From 2015 onwards, we used the spectra optia centrifugation system by terumo bct, denver, colorado.The change allowed for better access and increased frequency of tpe use in our patients.All patients underwent comprehensive blood tests (complete blood counts, renal profile, liver profiles, coagulation profile, and serum calcium) prior to commencement of tpe procedures.All vascular accesses were secured by a temporary double-lumen central venous catheter (11.5 fr/16 cm, 12 fr/15 cm) inserted by interventional radiologists.Five tpe exchange sessions were performed 24 h apart, that is, every other day.Regarding terumo bct product, spectra optia, there were five patients who developed line-related sepsis after receiving tpe treatment but recovered completely with appropriate antibiotic therapy.There were also four episodes of hypotension and eight episodes of hypocalcemia, which were treated accordingly.There were no coagulation abnormalities.Overall, tpe was well tolerated by the patients.Mortality was not directly associated with tpe treatment but rather the regressive course of the disease.Overall, authors concluded therapeutic plasma exchange (tpe) is an effective therapy in neuromyelitis optica spectrum disorder (nmosd) patients presenting with steroid refractory acute relapses per an internal technical report, the phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.Since this was a journal publication to assess to evaluate therapeutic plasma exchange (tpe) efficiency in treatment of a single relapse in steroid refractory patients with neuromyelitis optica spectrum disorders (nmosd) in a multi-ethnic resource-limited setting from an existing pool of nmosd patients attending the neurology clinic at kuala lumpur hospital from january 2005 to september 2018., the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.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.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (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.Adverse effects related to vascular access are a frequent concern.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.Root cause: based on the available information within the journal article, a definitive root cause could not be determined.Hypocalcemia occurs 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 rate of ac infusion, 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.The reported hypotension is a common side effect of therapeutic apheresis procedures.It is typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.According to the authors, the sepsis was line related.Causes more specifically could be due to: complications associated with prolonged use of catheter access inadequate maintenance of the patient¿s central venous access poor venipuncture technique leads to bacteria introduced at access site citation: ong, z.M., schee, j.P., & viswanathan, s.(2019).Therapeutic plasma exchange in neurom.Yelitis optica spectrum disorders and related disorders in resource-limited settings: outcomes in a multiethnic single-center population.Therapeutic apheresis and dialysis, 24(3), 312¿323.Https://doi.Org/10.1111/1744-9987.13446.

• 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: 19863575
• Report Number: 1722028-2024-00310
• Device Sequence Number: 15493736
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 07/05/2024
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 01/29/2025
• 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