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

Catalog Number	4121201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Diarrhea (1811)
Date of Event	04/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per journal article "engraftment after autologous hematopoietic stem cell transplantation in patients mobilized with plerixafor: a retrospective, multicenter study of a large series of patients".By, antelo, m.L., altuna, a., gimeno, j.J., ferreiro, j.J., amunárriz, c., mateos, j.J., zalba, s., alkorta, a., rifón, j., arroyo, j.L., uresandi, a., moreno, j.A., nájera, m.J., pinzón, s., garcía, a., vallejo, j.C.Abstract plerixafor (plx) appears to effectively enhance hematopoietic stem-cell mobilization prior to autologous hematopoietic stem cell transplantation (auto-hct).However, the quality of engraftment following auto-hct has been little explored.Here, engraftment following auto-hct was assessed in patients mobilized with plx through a retrospective, multicenter study of 285 consecutive patients.Information on early and 100-day post-transplant engraftment was gathered from the 245 patients that underwent auto-hct.The median number of plx days to reach the stem cell collection goal (=2 × 106 cd34+ cells/kg) was 1 (range 1¿4) and the median plx administration time before apheresis was 11 h (range 1¿18).The median number of apheresis sessions to achieve the collection goal was 2 (range 1¿5) and the mean number of cd34+ cells collected was 2.95 × 106/kg (range 0¿30.5).Plx administration was safe, with only 2 mild and transient gastrointestinal adverse events reported.The median time to achieve an absolute neutrophil count (anc) >500/¿l was 11 days (range 3¿31) and the median time to platelet recovery >20 × 103/¿l was 13 days (range 5¿69).At 100 days after auto-hct, the platelet count was 137 × 109/l (range 7¿340), the anc was 2.3 × 109/l (range 0.1¿13.0), and the hemoglobin concentration was 123 g/l (range 79¿165).Plx use allowed auto-hct to be performed in a high percentage of poorly mobilized patients, resulting in optimal medium-term engraftment in the majority of patients in whom mobilization failed, in this case mainly due to suboptimal peripheral blood cd34+ cell concentration on day +4 or low cd34+ cell yield on apheresis potential adverse event : in our series, there were 15 patients who had already received 1 previous auto-hct (15 mm & 1 lymphoma) and one patient who had received 2 previous auto-hct (mm).The median cd34 +/ kg obtained in this subgroup of patients was 2.8 ×106 cd34 / kg and the median number of apheresis sessions required was 2 per patient.Among the 285 patients, only 2 (0.8 %) reported aes following plx administration, including one case of abdominal discomfort and one case of diarrhea.Both these aes were mild and transient, and as such, plx was well tolerated in accordance with the established safety profile of the drug 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
Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: antelo, m.L., altuna, a., gimeno, j.J., ferreiro, j.J., amunárriz, c., mateos, j.J., zalba, s., alkorta, a., rifón, j., arroyo, j.L., uresandi, a., moreno, j.A., nájera, m.J., pinzón, s., garcía, a., & vallejo, j.C.(2021).Engraftment after autologous hematopoietic stem cell transplantation in patients mobilized with plerixafor: a retrospective, multicenter study of a large series of patients.Transfusion and apheresis science, 60(3), 103130.Https://doi.Org/10.1016/j.Transci.2021.103130.
Event or Problem Description
Per journal article "engraftment after autologous hematopoietic stem cell transplantation in patients mobilized with plerixafor: a retrospective, multicenter study of a large series of patients", by, antelo, m.L., altuna, a., gimeno, j.J., ferreiro, j.J., amunárriz, c., mateos, j.J., zalba, s., alkorta, a., rifón, j., arroyo, j.L., uresandi, a., moreno, j.A., nájera, m.J., pinzón, s., garcía, a., vallejo, j.C.Abstract plerixafor (plx) appears to effectively enhance hematopoietic stem-cell mobilization prior to autologous hematopoietic stem cell transplantation (auto-hct).However, the quality of engraftment following auto-hct has been little explored.Here, engraftment following auto-hct was assessed in patients mobilized with plx through a retrospective, multicenter study of 285 consecutive patients.Information on early and 100-day post-transplant engraftment was gathered from the 245 patients that underwent auto-hct.The median number of plx days to reach the stem cell collection goal (=2 × 106 cd34+ cells/kg) was 1 (range 1¿4) and the median plx administration time before apheresis was 11 h (range 1¿18).The median number of apheresis sessions to achieve the collection goal was 2 (range 1¿5) and the mean number of cd34+ cells collected was 2.95 × 106/kg (range 0¿30.5).Plx administration was safe, with only 2 mild and transient gastrointestinal adverse events reported.The median time to achieve an absolute neutrophil count (anc) >500/ l was 11 days (range 3¿31) and the median time to platelet recovery >20 × 103/ l was 13 days (range 5¿69).At 100 days after auto-hct, the platelet count was 137 × 109/l (range 7¿340), the anc was 2.3 × 109/l (range 0.1¿13.0), and the hemoglobin concentration was 123 g/l (range 79¿165).Plx use allowed auto-hct to be performed in a high percentage of poorly mobilized patients, resulting in optimal medium-term engraftment in the majority of patients in whom mobilization failed, in this case mainly due to suboptimal peripheral blood cd34+ cell concentration on day +4 or low cd34+ cell yield on apheresis potential adverse event: in our series, there were 15 patients who had already received 1 previous auto-hct (15 mm & 1 lymphoma) and one patient who had received 2 previous auto-hct (mm).The median cd34 +/ kg obtained in this subgroup of patients was 2.8 ×106 cd34 / kg and the median number of apheresis sessions required was 2 per patient.Among the 285 patients, only 2 (0.8 %) reported aes following plx administration, including one case of abdominal discomfort and one case of diarrhea.Both these aes were mild and transient, and as such, plx was well tolerated in accordance with the established safety profile of the drug 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: lot number, manufacture and expiry date are not available at this time.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 ae reactions were plx-related and were mild, with no medical intervention required and the death was due to transplant related mortality (neutropenic infection).There is no direct allegation against the tbct devices.No further reporting will be provided as this does not represent a reportable event.Citation: antelo, m.L., altuna, a., gimeno, j.J., ferreiro, j.J., amunárriz, c., mateos, j.J., zalba, s., alkorta, a., rifón, j., arroyo, j.L., uresandi, a., moreno, j.A., nájera, m.J., pinzón, s., garcía, a., & vallejo, j.C.(2021).Engraftment after autologous hematopoietic stem cell transplantation in patients mobilized with plerixafor: a retrospective, multicenter study of a large series of patients.Transfusion and apheresis science, 60(3), 103130.Https://doi.Org/10.1016/j.Transci.2021.103130.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECT 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: 20126858
• Report Number: 1722028-2024-00367
• Device Sequence Number: 18013008
• Product Code: LKN
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• 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): 09/03/2024

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: 4121201
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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