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

Catalog Number	10220
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arrhythmia (1721); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article "therapeutic plasma exchange in critically ill children: a single center experience" by yazici ozkaya, p., ko¿¿, g., ersayo¿¿lu, ¿¿., cebeci, k., hekimci ozdemir, h., karadas, n., yilmaz karapinar, d., karapinar, b.Potential adverse event : adverse events were observed in 68 (13.9%) sessions.Hypotension (7.8%) and hypocalcemia (5.1%) were thet a b l e 1 indications for therapeutic plasma exchange and disease category.Clinical diagnosis patients (%) (n = 154) number of tpe sessions (n = 486) asfa categorysepsis with multiorgan dysfunction syndrome 42 (27.3) 104sepsis + previously healthy 15 (9.7) 34 iiisepsis + co-morbidity 27 (17.6) 70 iiihemophagocytic lymphohistiocytosis 14 (9.1) 49 iiiliver diseases 48 (31.2) 148acute liver failure 43 (28) 127 iiiwilson disease 5 (3.2) 21 irheumatological diseases 4 (2.6) 34systemic lupus erythematosus 3 (1.9) 30 iigranulomatosis with polyangiitis (gpa) 1 (0.7) 4 iiithrombotic microangiopathy 15 (9.7) 68complement mediated 10 (6.5) 45 iiiinfection mediated (stec hus) 1 (0.6) 5 iiitma, transplantation associated 2 (1.3) 8 iiithrombotic thrombocytopenic purpura 2 (1.3) 10 ipoisoning 21 (13.6) 37mushroom poisoning 11 (7.1) 25 iidrug poisoning 10 (6.5) 17 iiineurological diseases 10 (6.5) 46adem 3 (1.9) 21 iinmda receptor antibody encephalitis 1 (0.6) 10 iacute inflammatory demyelinatingpolyradiculoneuropathy5 (3.2) 18 imultiple sclerosis 1 (0.6) 2 iiabbreviations: adem, acute disseminated encephalomyelitis; asfa, american society for apheresis; hus, hemolytic uremic syndrome; nmda, n-methyl-d-aspartate receptor antibody encephalitis; stec, shiga toxin-producing escherichia coli; tma, thrombotic microangiopathy; tpe, therapeutic plasmaexchange.Yazici ¿¿zkaya et al.795most frequent adverse events followed by arrythmia(11.2%), allergic reaction (11.2%), and transfusion related-acute lung injury (0.2%).None of the patient complica-tions resulted in premature discontinuation of the proce-dure.Catheter malfunction was observed in 14 sessions(2.8%).The occurrence of catheter related problems wassignificantly associated with a lower weight (39.6% for¿¿¿10 kg children, 25.1% for ¿¿¿10 kg children, p = 0.005).There was no mortality secondary to tpe.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.
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Citation: zkaya, p.Y., ko, g., ersayo lu., cebeci, k., zdemir, h.H., karadas, n., karapinar, d.Y., & karapinar, b.(2024).Therapeutic plasma exchange in critically ill children: a single center experience.Therapeutic apheresis and dialysis.Https://doi.Org/10.1111/1744-9987.14141.Investigation is in process; a follow-up report will be provided.
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Citation: özkaya, p.Y., koç, g., ersayoglu, i., cebeci, k., özdemir, h.H., karadas, n., karapinar, d.Y., & karapinar, b.(2024).Therapeutic plasma exchange in critically ill children: a single center experience.Therapeutic apheresis and dialysis.Https://doi.Org/10.1111/1744-9987.14141 further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.There was no alleged medical intervention against a tbct device.No further reporting will be provided as this does not represent a reportable event. .
Event or Problem Description
Per journal article "therapeutic plasma exchange in critically ill children: a single center experience" by yazici ozkaya, p., koç, g., ersayoglu, i., cebeci, k., hekimci ozdemir, h., karadas, n., yilmaz karapinar, d., karapinar, b.Potential adverse event : adverse events were observed in 68 (13.9%) sessions.Hypotension (7.8%) and hypocalcemia (5.1%) were thet a b l e 1 indications for therapeutic plasma exchange and disease category.Clinical diagnosis patients (%) (n = 154) number of tpe sessions (n = 486) asfa categorysepsis with multiorgan dysfunction syndrome 42 (27.3) 104sepsis + previously healthy 15 (9.7) 34 iiisepsis + co-morbidity 27 (17.6) 70 iiihemophagocytic lymphohistiocytosis 14 (9.1) 49 iiiliver diseases 48 (31.2) 148acute liver failure 43 (28) 127 iiiwilson disease 5 (3.2) 21 irheumatological diseases 4 (2.6) 34systemic lupus erythematosus 3 (1.9) 30 iigranulomatosis with polyangiitis (gpa) 1 (0.7) 4 iiithrombotic microangiopathy 15 (9.7) 68complement mediated 10 (6.5) 45 iiiinfection mediated (stec hus) 1 (0.6) 5 iiitma, transplantation associated 2 (1.3) 8 iiithrombotic thrombocytopenic purpura 2 (1.3) 10 ipoisoning 21 (13.6) 37mushroom poisoning 11 (7.1) 25 iidrug poisoning 10 (6.5) 17 iiineurological diseases 10 (6.5) 46adem 3 (1.9) 21 iinmda receptor antibody encephalitis 1 (0.6) 10 iacute inflammatory demyelinatingpolyradiculoneuropathy5 (3.2) 18 imultiple sclerosis 1 (0.6) 2 iiabbreviations: adem, acute disseminated encephalomyelitis; asfa, american society for apheresis; hus, hemolytic uremic syndrome; nmda, n-methyl-d-aspartate receptor antibody encephalitis; stec, shiga toxin-producing escherichia coli; tma, thrombotic microangiopathy; tpe, therapeutic plasmaexchange.Yazici özkaya et al.795most frequent adverse events followed by arrythmia(11.2%), allergic reaction (11.2%), and transfusion related-acute lung injury (0.2%).None of the patient complica-tions resulted in premature discontinuation of the proce-dure.Catheter malfunction was observed in 14 sessions(2.8%).The occurrence of catheter related problems wassignificantly associated with a lower weight (39.6% for<10 kg children, 25.1% for >10 kg children, p = 0.005).There was no mortality secondary to tpe.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: 20400227
• Report Number: 1722028-2024-00433
• Device Sequence Number: 19670784
• 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,Followup
• Report Date (Section B): 10/08/2024

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: 09/13/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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 Sex: Unknown