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); Urticaria (2278); Swelling/ Edema (4577)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Delamain, m., gontijo, p., santos, f., matos c., nascimento, v., miranda, d., coelho, m., diniz, a., oliveira, r., porto, t., & costa, a.(2023).Plasmaf rese teraputica: avalia o dos procedimentos de acordo com as diretrizes internacionais.Hematology, transfusion and cell therapy, 45, s688-s689.Https://doi.Org/10.1016/j.Htct.2023.09.1252.
Event or Problem Description
Per journal article "plasmaf rese terap utica: avalia o dos procedimentos de acordo com as diretrizes internacionais".By, delamain, m.T., gontijo, p.C., santos, f.S.D., matos, c.T.S., nascimento, v.Z.D., miranda, d.M., coelho, m.V.P., diniz, a.P., oliveira, r.A.S.F., porto, t.H.A., costa, a.L.Potential adverse event: 4 patients were identified who presented adverse reaction during the procedure, 1 being a febrile reaction non-hemolytic to plasma, 1 arterial hypotension, 1 reflex vasovagal and arterial hypotension and 1 patient presented ~ edema of the tongue, eyelids and urticaria on the face.As for the indication criteria, the vast majority of procedures" 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 b.5, h.6 and h.11.Investigation: since this was a journal publication to assess therapeutic plasmapheresis by evaluating procedures according to international guidelines between (b)(6) 2021 and (b)(6) 2023, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.Since this was a journal publication to assess therapeutic plasmapheresis by evaluating procedures according to international guidelines between april 2021 and june 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.Between (b)(6) 2021 and (b)(6) 2023, 66 patients were evaluated, 62% of whom were female, with a median age of 38 years (5-93) who underwent the therapeutic plasmapheresis procedure, totaling 289 procedures.The main diagnoses found were: post-heart transplant rejection, acute post-kidney transplant rejection, neuromyelitis optica, thrombotic thrombocytopenic purpura (ttp), waldenstrom macroglobulinemia, malt non-hodgkin's lymphoma, multiple myeloma, myasthenia gravis, hemolytic uremic syndrome, and guillain-barré.The most commonly used replacement fluid was albumin, with the exception of ttp cases.The equipment used was haemonectics® and spectra optia-terumo®.Of the total number of patients treated, about 30% underwent the procedures in the icu, the others in beds in the common ward.We identified 4 patients who had an adverse reaction during the procedure, 1 of which was a non-hemolytic febrile reaction to plasma, 1 was hypotension, 1 was a vasovagal reflex and hypotension, and 1 patient had edema of the tongue, eyelids and urticaria on the face.Regarding the indication criteria, the vast majority of procedures are in accordance with the recommendations of the asfa protocol, with regard to recommendation and degree of evidence.Discussion: during the period evaluated, a significant number of patients were indicated for plasmapheresis as a therapeutic alternative, either associated with the basic treatment or as the first line of treatment.The procedure proved to be safe and well tolerated in almost all patients, and the indications were precise and in accordance with the recommendations found in the literature.Conclusion: therapeutic plasmapheresis has a well-defined role with a high degree of recommendation and evidence in certain pathologies.In addition to the evaluation of the indication by pathology, clinical studies are also necessary to assist in decision-making regarding the most appropriate propaedeutic and therapeutic in favor of the patient.According to the aabb circular of information for the use of human blood components (revised 2017), febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.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: based on the available information within the journal article, a definitive root cause could not be determined.The journal alleged that 4 patients experienced an adverse reaction during the procedure, 1 of which was a non-hemolytic febrile reaction to plasma, 1 was hypotension, 1 was a vasovagal reflex and hypotension, and 1 patient had edema of the tongue, eyelids and urticaria on the face.The authors documented that the febrile non-hemolytic reaction was due to plasma.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.It is likely the reactions were caused by the presence of recipient antibodies (raised as a result of previous transfusions) reacting to donor human leucocyte antigens (hla) or other antigens.It is also widely known that febrile reactions are caused by passively transfused cytokines or recipient antibodies reacting with leukocytes in the blood product.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.Symptoms of allergic reaction is likely due to one or a combination of the possible causes listed below: * hypersensitivity to the ethylene oxide used to sterilize the disposable set * hypersensitivity to the components inside the disposable set * patient¿s underlying disease state or sensitivity to the apheresis procedure citation: delamain, m., gontijo, p., santos, f., matos, c., nascimento, v., miranda, d., coelho, m., diniz, a., oliveira, r., porto, t., & costa, a.(2023).Plasmaférese terapêutica: avaliação dos procedimentos de acordo com as diretrizes internacionais.Hematology, transfusion and cell therapy, 45, s688-s689.Https://doi.Org/10.1016/j.Htct.2023.09.1252.
Event or Problem Description
Per journal article "plasmaférese terapêutica: avaliação dos procedimentos de acordo com as diretrizes internacionais".By, delamain, m.T., gontijo, p.C., santos, f.S.D., matos, c.T.S., nascimento, v.Z.D., miranda, d.M., coelho, m.V.P., diniz, a.P., oliveira, r.A.S.F., porto, t.H.A., costa, a.L.Potential adverse event : 4 patients were identified who presented adverse reaction during the procedure, 1 being a febrile reaction non-hemolytic to plasma, 1 arterial hypotension, 1 reflex vasovagal and arterial hypotension and 1 patient presented ~ edema of the tongue, eyelids and urticaria on the face.As for the indication criteria, the vast majority of procedures" 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.His was a journal publication to assess therapeutic plasmapheresis by evaluating procedures according to international guidelines between april 2021 and june 2023, where 66 patients were evaluated, 62% of whom were female, with a median age of 38 years (5-93).A request for specific patient information is not feasible.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: 19962610
• Report Number: 1722028-2024-00339
• Device Sequence Number: 8731952
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/12/2024

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: 07/19/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 02/19/2025
• 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