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

Catalog Number	10220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Tachycardia (2095)
Date of Event	05/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: acquired thrombotic thrombocytopenic purpura (attp) is a rare, life-threatening condition characterized by microangiopathic hemolytic anemia, thrombocytopenia, and marked reduction in adamts13 activity by anti- adamts13 antibodies.The rates of ttp-related death and relapses were 9% and 24%, respectively.Thus, early diagnosis is crucial for these patients.Plasmapheresis is the main treatment for removing adamts-13 antibodies from plasma.It requires a central venous catheter (cvc); however, unexpected complications can develop during plasmapheresis procedure.Ttp patients are more prone to develop microvascular thrombosis, while macrovascular thrombosis is rarely seen.In a comprehensive review, mobile right atrial thrombus measuring more than 2 cm are strong indicator of thrombolytic treatment.This is the first case of a 17-year-old girl with attp who developed an intracardiac thrombus after plasmapheresis and resolved with catheter-directed thrombolytic therapy.She had been experiencing headaches, numbness in both arms, and various bruises for at least 35 days.Her complete blood count (cbc) showed a low hemoglobin level of 10.5 g/dl, a low platelet count of 15 000/¿l, a high reticulocyte percentage of 4%, and a high lactate dehydrogenase level of 705 u/l.Peripheral blood smear revealed rare schistocytes.Our patient was diagnosed with attp based on a low adamts-13 activity level of <0.2% (normal range: 40%¿130%) and an inhibitor level of 44.12 u/ml (normal level <12 u/ml).Plasmapheresis was scheduled due to her heavy menstrual bleeding, which required numerous platelets, fresh frozen plasma (ffp) infusions, and tranexamic acid.Cvc was inserted into the right jugular veins, and the catheter tip was observed in the right atrium before plasmapheresis.After 5 days of plasmapheresis using ffp with acid citrate dextrose-a (inlet/anticoagulation rate of 1:10) in spectra optia (tokyo, japan), thrombocytopenia was resolved, and the menorrhagia was under control.On day 7 following plasmapheresis, our patient experienced chest pain, tachycardia, and dyspnea.Her d-dimer level was 32.95 mg/dl (normal <0.5 mg/dl).Her echocardiography indicated a mobile, large thrombosis-sized 2.6 x 1.7 cm in the right atrium.Tissue plasminogen activator (0.01¿0.02 mg/kg/h) and unfractionated heparin (5¿10 u/kg/h) were administered by cvc at 6-h intervals for 3 days.Control echocardiography revealed that the fixed thrombus in the right atrium wall had decreased to 1.0 x 0.8 cm, thus the catheter was removed.The control d-dimer level turned to the normal range of 0.42 mg/dl.After discharge, patients were given 100 iu/kg/dose of low-molecular weight heparin twice a day with anti-factor xa monitoring.Her platelet count began to decrease again.Rituximab at a dose of 375 mg/m2 weekly was utilized to reduce attp recurrence risk.After four doses of rituximab, adamts-13 activity exceeded 94%, and the adamts-13 inhibitor became negative.The patient's clinical condition improved, and her platelet counts remained within normal levels during the 6-month follow-up period.Based on these findings, we conclude that the plasmapheresis procedure, cvc, platelet transfusion, tranexamic acid administration, and attp were all responsible for the development of intracardiac thrombus in our case.Furthermore, rituximab for attp and catheter-directed thrombolytic therapy for massive thrombus can be effective therapies in such complicated cases.Since this was a journal publication from may 2024 to evaluate the development of an intracardiac thrombus after plasmapheresis, 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.According to therapeutic apheresis: a physician's handbook, 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.The cause of a cvc flow problem may sometimes be difficult to determine, although patient repositioning will sometimes improve flow.A common situation is that the cvc can be flushed without resistance but does not yield blood return; this scenario may be the result of kinking, poor positioning, intralumenal clots, or venous thrombosis.Blocked cvcs can sometimes be cleared with a fibrinolytic agent such as tpa.The placement of a cvc is considered by some to be the greatest risk related to the apheresis procedures, and it should be avoided if the procedure can be performed using peripheral iv.Root cause: a root cause assessment was performed for the development of intracardiac thrombus.The author concluded that ¿the plasmapheresis procedure, cvc, platelet transfusion, tranexamic acid administration, and attp were all responsible for the development of intracardiac thrombus in our case.Kilinç, b., canbeyli, f.H., yazici, m.U., & kaya, z.(2024).Life-threatening intracardiac thrombus after plasmapheresis in a child with acquired thrombotic thrombocytopenic purpura.Therapeutic apheresis and dialysis, 28(6), 969-970.Https://doi.Org/10.1111/1744-9987.14210.
Event or Problem Description
Per journal article "life-threatening intracardiac thrombus after plasmapheresis in a child with acquired thrombotic thrombocytopenic purpura" by kilinç, b., canbeyli, f.H., yazici, m.U., & kaya, z.¿this is the first case of a 17-year-old girl with attp who developed an intracardiac thrombus after plasmapheresis and resolved with catheter-directed thrombolytic therapy¿.Based on these findings, we conclude that the plasmapheresis procedure, cvc, platelet transfusion, tranexamic acid administration, and attp were all responsible for the development of intracardiac thrombus in our case." 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: 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: 21584489
• Report Number: 1722028-2025-00054
• Device Sequence Number: 9275703
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 03/12/2025

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: 02/19/2025
• Initial Report FDA Received Date: 03/12/2025
• 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 Age: 17 YR
• Patient Sex: Female