MAUDE Adverse Event Report: TERUMO BCT SPECTA OPTIA; SPECTRA OPTIA IDL SET

Catalog Number	10310
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
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.Citation: oarbeascoa, g., lozano, m.L., guerra, l.M., amunarriz, c., saavedra, c.A., garcia-gala, j.M., viejo, a., revilla, n., fleitas, c.A., arroyo, j.L., revuelta, e.M., galego, a., hernandez-maraver, d., kwon, m., diez-martin, j.L., & pascual, c.(2020).Retrospective multicenter study of extracorporeal photopheresis in steroid-refractory acute and chronic graft-versus-host disease. biology of blood and marrow transplantation, 26(4), 651¿658. https://doi.Org/10.1016/j.Bbmt.2019.12.769.
Event or Problem Description
Per journal article "retrospective multicenter study of extracorporeal photopheresis in steroid-refractory acute and chronic graft-versus-host disease" by gillen oarbeascoa, maria luisa lozano, luisa maria guerra, cristina amunarriz, concepcion andon saavedra, jose maria garcia-gala, aurora viejo, nuria revilla, cynthia acosta fleitas, jose luis arroyo, eva martinez revuelta, andrea galego, dolores hernandez-maraver, mi kwon, jose luis diez-martin, cristina pascual extracorporeal photopheresis (ecp) is an established treatment strategy in steroid-refractory graft-versus-host disease (gvhd).This study¿s main objective was to analyze the clinical response and impact of ecp therapy in steroid dose reduction.A retrospective observational series of 113 patients from 7 transplantation centers was analyzed.Sixty-five patients (58%) had acute gvhd (agvhd), and 48 (42%) had chronic gvhd (cgvhd).All ecp procedures were performed with the off-line system.The median number of procedures until achievement of initial response was 3 for both patients with agvhd and those with cgvhd.Ecp was the second-line therapy in 48% of the agvhd cases and in 50% of the cgvhd cases.71% of the cases of agvhd were grade iii-iv, and 69% of the cases of cgvhd were severe.The overall response rate on day 28 was 53% (complete response [cr] rate, 45%) in the patients with agvhd and 67% (cr, 23%) in those with cgvhd.Skin was the most frequently involved organ, with a response rate of 58% (cr, 49%) in the patients with agvhd and 69% (cr 29%) in those with cgvhd.At the end of ecp treatment, 60% of patients treated for agvhd who responded were able to stop steroid therapy, with a median dose reduction of 100%.Significant differences in overall survival were observed for patients responding to ecp with agvhd (hazard ratio [hr], 4.3; p <.001) and with cgvhd (hr, 4.8; p =.003).Our data indicate that ecp is a valid therapeutic alternative in patients with steroid-refractory agvhd and cgvhd, permitting significant steroid dosage reductions.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 h.6 and h.11.Investigation: 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.It was confirmed that the the deaths are not related to the device/disposable or procedure.Lot number, manufacture and expiry date are not available at this time.No further reporting will be provided as this does not represent a reportable event.Citation: oarbeascoa, g., lozano, m.L., guerra, l.M., amunarriz, c., saavedra, c.A., garcia-gala, j.M., viejo, a., revilla, n., fleitas, c.A., arroyo, j.L., revuelta, e.M., galego, a., hernandez-maraver, d., kwon, m., diez-martin, j.L., & pascual, c.(2020).Retrospective multicenter study of extracorporeal photopheresis in steroid-refractory acute and chronic graft-versus-host disease.Biology of blood and marrow transplantation, 26(4), 651¿658.Https://doi.Org/10.1016/j.Bbmt.2019.12.769.
Event or Problem Description
Per journal article "retrospective multicenter study of extracorporeal photopheresis in steroid-refractory acute and chronic graft-versus-host disease" by gillen oarbeascoa, maria luisa lozano, luisa maria guerra, cristina amunarriz, concepcion andon saavedra, jose maria garcia-gala, aurora viejo, nuria revilla, cynthia acosta fleitas, jose luis arroyo, eva martinez revuelta, andrea galego, dolores hernandez-maraver, mi kwon, jose luis diez-martin, cristina pascual extracorporeal photopheresis (ecp) is an established treatment strategy in steroid-refractory graft-versus-host disease (gvhd).This study¿s main objective was to analyze the clinical response and impact of ecp therapy in steroid dose reduction.A retrospective observational series of 113 patients from 7 transplantation centers was analyzed.Sixty-five patients (58%) had acute gvhd (agvhd), and 48 (42%) had chronic gvhd (cgvhd).All ecp procedures were performed with the off-line system.The median number of procedures until achievement of initial response was 3 for both patients with agvhd and those with cgvhd.Ecp was the second-line therapy in 48% of the agvhd cases and in 50% of the cgvhd cases.71% of the cases of agvhd were grade iii-iv, and 69% of the cases of cgvhd were severe.The overall response rate on day 28 was 53% (complete response [cr] rate, 45%) in the patients with agvhd and 67% (cr, 23%) in those with cgvhd.Skin was the most frequently involved organ, with a response rate of 58% (cr, 49%) in the patients with agvhd and 69% (cr 29%) in those with cgvhd.At the end of ecp treatment, 60% of patients treated for agvhd who responded were able to stop steroid therapy, with a median dose reduction of 100%.Significant differences in overall survival were observed for patients responding to ecp with agvhd (hazard ratio [hr], 4.3; p <.001) and with cgvhd (hr, 4.8; p =.003).Our data indicate that ecp is a valid therapeutic alternative in patients with steroid-refractory agvhd and cgvhd, permitting significant steroid dosage reductions.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.

• Brand Name: SPECTA OPTIA
• Common Device Name: SPECTRA OPTIA IDL 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: 19425619
• Report Number: 1722028-2024-00199
• Device Sequence Number: 7905716
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10310
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 10/17/2024
• 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