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); Vomiting (2144)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article "role of plasma exchange in a steroid- and ivig-refractory patient with acute disseminated encephalomyelitis: a case report" by tripathi, p.P., hans, r., sharma, r.R., lamba, d.S., paul, p., sankhyan, n., bhagwat, c., & singh, p.(2020), an 8-year boy presented with limb weakness and complete loss of vision and was resistant to steroid therapy.He was further treated with therapeutic plasma exchange (tpe) and five sessions were given on every alternate day using a central femoral line dialysis catheter as vascular access on automated cell separators cobe spectra and optia spectra.A total of 4% of human serum albumin was used as replacement fluid during each session of plasma exchange.During each session, 1% calcium gluconate infusion was given through venular access to overcome any complications related to hypocalcemia.All tpe procedures were uneventful except for the first one where the patient complained of shivering followed by vomiting and hypotension which was managed conservatively with intravenous fluid 0.9% normal saline bolus.After completion of the tpe sessions, the patient showed improvement in vision and started to regain his power.He was discharged on day 18 of hospital stay and had a motor power in the right lower limb of 4/5, in the left lower limb of 3/5, in the left upper limb of 3/5, and in the right upper limb of 3/5.During follow-up, the patient looked healthy and able to walk independently.The first visit was after 1 month of discharge, where a second dose of pulse cyclophosphamide was given.During the second visit, 2 months after discharge, the patient gave history of full recovery from neurological deficits, and the third dose of cyclophosphamide was given.He was able to play and able to do normal daily routine activities.His vision improved.Left eye vision improved fully with vision 6/6.The patient still complained of blurring of vision in the right eye.But he was able to recognize faces and appreciate hand movement from the right eye with vision 6/9.For this, an ophthalmologist consultation was advised.At 3 months of follow-up, the child was able to walk independently, and vision also improved to 6/6 in both eyes.Patient identification is unknown.Patient is reported to have made a full recovery from neurological deficits.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Lot number and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Tripathi, p.P., hans, r., sharma, r.R., lamba, d.S., paul, p., sankhyan, n., bhagwat, c., & singh, p.(2020).Role of plasma exchange in a steroid- and ivig-refractory patient with acute disseminated encephalomyelitis: a case report.Transfusion medicine and hemotherapy, 47(5), 420¿423.Https://doi.Org/10.1159/000504987.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: an investigation was conducted for journal article that references terumo bct product.Journal article, titled ¿role of plasma exchange in a steroid- and ivig-refractory patient with acute disseminated encephalomyelitis: a case report¿ by singh et al.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.Regarding terumo bct product, cobe spectra and spectra optia, which was used for therapeutic plasma exchange for a patient diagnosed with acute disseminated encephalomyelitis (adem).All tpe procedures were uneventful except for the first one where the patient complained of shivering followed by vomiting and hypotension which was managed conservatively with intravenous fluid 0.9% normal saline bolus.During each session, 1% calcium gluconate infusion was given through venular access to overcome any complications related to hypocalcemia.Adem is a rare disease in the pediatric age group and related to immune-mediated pathogenesis.Treatment of adem includes specific high-dose intravenous methylprednisolone, intravenous immunoglobulin (ivig), and plasma exchanges along with physical and rehabilitation therapy.However, the role of plasma exchange in adem is helpful in those patients who are unresponsive or poorly respond to steroid therapy.According to asfa 2019, therapeutic plasma exchange (tpe) for adem comes under category ii (grade 2c).The effectiveness and ability of plasma exchange is to remove offending circulating antibodies.This journal article focuses on a case report detailing an 8-year-old boy developed progressive limbs weakness that progressed to a bedridden stage over 12 h.He was treated with steroid pulse therapy (injection methylprednisolone 750 mg/day for 3 days) and ivig therapy (1 g/kg/day for 2 days).Later, the child also complained of transient loss of vision followed by bilateral complete loss of vision.On examination, there was complete loss of vision with no perception of light in the eyes.On cns examination, deep tendon reflexes were elicited able with generalized hypotonia and left hemiparesis.The power strength in the right upper and lower limb was 4/5.Power strength in the left upper and lower limbs were 1/5 and 1/5, respectively.All routine investigations were within the normal range.Antibody testing for nmomog (neuromyelitis optica-myelin oligodendrocyte glycoprotein) and aquaporin igg4 were negative.Mri brain showed multiple subcortical hyperintense lesions of varying sizes on t2w and flair images in both cerebral hemispheres based on the clinical history and mri radiological findings, a diagnosis of adem (tumefactive, necrotizing demyelination) was concluded.As the patient was a poor responder to steroids and ivig, the next line of treatment for tpe was planned.On the third day of admission, the first session of tpe was initiated.In total, five sessions were given on every alternate day using a central femoral line dialysis catheter as vascular access on automated cell separators cobe®spectra and optia®spectra (terumo bct; lakewood, co, usa).A total of 4% of human serum albumin was used as replacement fluid during each session of plasma exchange.All tpe procedures were uneventful except for the first one where the patient complained of shivering followed by vomiting and hypotension which was managed conservatively with intravenous fluid 0.9% normal saline bolus.After completion of the tpe sessions, the patient showed improvement in vision and started to regain his power.He was discharged on day 18 of hospital stay and had a motor power in the right lower limb of 4/5, in the left lower limb of 3/5, in the left upper limb of 3/5, and in the right upper limb of 3/5.During follow-up, the patient looked healthy and able to walk independently.The first visit was after 1 month of discharge, where a second dose of pulse cyclophosphamide was given.During the second visit, 2 months after discharge, the patient gave history of full recovery from neurological deficits, and the third dose of cyclophosphamide was given.At 3 months of follow-up, the child was able to walk independently, and vision also improved to 6/6 in both eyes.The authors concluded that tpe may be an effective regimen or at least adjuvant therapy along with steroids in these patients.In this case study, the paediatric adem patient completely recovered post- tpe and is in follow-up.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.Since this was a journal publication to discuss a case study, retrospectively, the lot numbers were not requested and therefore a disposable lot history search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: 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.Citation: tripathi, p.P., hans, r., sharma, r.R., lamba, d.S., paul, p., sankhyan, n., bhagwat, c., & singh, p.(2020).Role of plasma exchange in a steroid- and ivig-refractory patient with acute disseminated encephalomyelitis: a case report.Transfusion medicine and hemotherapy, 47(5), 420¿423.Https://doi.Org/10.1159/000504987.
Event or Problem Description
Per journal article "role of plasma exchange in a steroid- and ivig-refractory patient with acute disseminated encephalomyelitis: a case report" by tripathi, p.P., hans, r., sharma, r.R., lamba, d.S., paul, p., sankhyan, n., bhagwat, c., & singh, p.(2020), an 8-year boy presented with limb weakness and complete loss of vision and was resistant to steroid therapy.He was further treated with therapeutic plasma exchange (tpe) and five sessions were given on every alternate day using a central femoral line dialysis catheter as vascular access on automated cell separators cobe spectra and optia spectra.A total of 4% of human serum albumin was used as replacement fluid during each session of plasma exchange.During each session, 1% calcium gluconate infusion was given through venular access to overcome any complications related to hypocalcemia.All tpe procedures were uneventful except for the first one where the patient complained of shivering followed by vomiting and hypotension which was managed conservatively with intravenous fluid 0.9% normal saline bolus.After completion of the tpe sessions, the patient showed improvement in vision and started to regain his power.He was discharged on day 18 of hospital stay and had a motor power in the right lower limb of 4/5, in the left lower limb of 3/5, in the left upper limb of 3/5, and in the right upper limb of 3/5.During follow-up, the patient looked healthy and able to walk independently.The first visit was after 1 month of discharge, where a second dose of pulse cyclophosphamide was given.During the second visit, 2 months after discharge, the patient gave history of full recovery from neurological deficits, and the third dose of cyclophosphamide was given.He was able to play and able to do normal daily routine activities.His vision improved.Left eye vision improved fully with vision 6/6.The patient still complained of blurring of vision in the right eye.But he was able to recognize faces and appreciate hand movement from the right eye with vision 6/9.For this, an ophthalmologist consultation was advised.At 3 months of follow-up, the child was able to walk independently, and vision also improved to 6/6 in both eyes.Patient identification is unknown.Patient is reported to have made a full recovery from neurological deficits.The 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: 19575017
• Report Number: 1722028-2024-00265
• Device Sequence Number: 4160200
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 05/27/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 12/26/2024
• 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
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 27 KG