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

Catalog Number	4123201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article ""therapeutic white blood cell and platelet depletions using the spectra optia system continuous mononuclear cell protocol"".By nancy c.Cates, , darlene j.Oakley, , oluwatoyosi a.Onwuemene, abstract the spectra optia apheresis system® has only recently been approved by the food and drug administration (fda) for therapeutic white blood cell (wbc) and is not yet approved for platelet depletions.Prior to fda-approval of the wbc depletion protocol, when our available cobe spectra apheresis systems were out of service, we successfully performed wbc depletion using a modified spectra optia apheresis system continuous mononuclear cell (cmnc) protocol.Using this modified spectra optia cmnc protocol, we created institutional protocols for wbc and platelet depletions.We performed 10 wbc depletions in 9 patients and 2 platelet depletions in 2 patients.We compared pre- and post-procedure wbc, platelet count, and hemoglobin to the same data from patients previously treated on the cobe spectra and found no difference in % wbc and platelet reduction.We also found no significant difference in post-procedural hematocrit decline.Additionally, adverse reactions were not increased.Therefore, we conclude that the spectra optia cmnc protocol can be successfully modified for effective wbc and platelet depletions without increase in adverse reactions.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.Cates, n.C., oakley, d.J., & onwuemene, o.A.(2018).Therapeutic white blood cell and platelet depletions using the spectra optia system continuous mononuclear cell protocol. journal of clinical apheresis, 33(5), 580¿585. https://doi.Org/10.1002/jca.21644.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.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.This journal was published in 2019, the current devices in field have product and software changes that were not in place for devices used more than 5 years ago.No further reporting will be provided as this does not represent a reportable event.Cates, n.C., oakley, d.J., & onwuemene, o.A.(2018).Therapeutic white blood cell and platelet depletions using the spectra optia system continuous mononuclear cell protocol.Journal of clinical apheresis, 33(5), 580¿585.Https://doi.Org/10.1002/jca.21644.
Event or Problem Description
Per journal article ""therapeutic white blood cell and platelet depletions using the spectra optia system continuous mononuclear cell protocol"".By nancy c.Cates, , darlene j.Oakley, , oluwatoyosi a.Onwuemene, abstract the spectra optia apheresis system® has only recently been approved by the food and drug administration (fda) for therapeutic white blood cell (wbc) and is not yet approved for platelet depletions.Prior to fda-approval of the wbc depletion protocol, when our available cobe spectra apheresis systems were out of service, we successfully performed wbc depletion using a modified spectra optia apheresis system continuous mononuclear cell (cmnc) protocol.Using this modified spectra optia cmnc protocol, we created institutional protocols for wbc and platelet depletions.We performed 10 wbc depletions in 9 patients and 2 platelet depletions in 2 patients.We compared pre- and post-procedure wbc, platelet count, and hemoglobin to the same data from patients previously treated on the cobe spectra and found no difference in % wbc and platelet reduction.We also found no significant difference in post-procedural hematocrit decline.Additionally, adverse reactions were not increased.Therefore, we conclude that the spectra optia cmnc protocol can be successfully modified for effective wbc and platelet depletions without increase in adverse reactions.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 a correction in d.2b.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.This journal was published in 2019, the current devices in field have product and software changes that were not in place for devices used more than 5 years ago.No further reporting will be provided as this does not represent a reportable event.Cates, n.C., oakley, d.J., & onwuemene, o.A.(2018).Therapeutic white blood cell and platelet depletions using the spectra optia system continuous mononuclear cell protocol.Journal of clinical apheresis, 33(5), 580¿585.Https://doi.Org/10.1002/jca.21644.
Event or Problem Description
Per journal article "therapeutic white blood cell and platelet depletions using the spectra optia system continuous mononuclear cell protocol".By nancy c.Cates, darlene j.Oakley, oluwatoyosi a.Onwuemene, abstract the spectra optia apheresis system® has only recently been approved by the food and drug administration (fda) for therapeutic white blood cell (wbc) and is not yet approved for platelet depletions.Prior to fda-approval of the wbc depletion protocol, when our available cobe spectra apheresis systems were out of service, we successfully performed wbc depletion using a modified spectra optia apheresis system continuous mononuclear cell (cmnc) protocol.Using this modified spectra optia cmnc protocol, we created institutional protocols for wbc and platelet depletions.We performed 10 wbc depletions in 9 patients and 2 platelet depletions in 2 patients.We compared pre- and post-procedure wbc, platelet count, and hemoglobin to the same data from patients previously treated on the cobe spectra and found no difference in % wbc and platelet reduction.We also found no significant difference in post-procedural hematocrit decline.Additionally, adverse reactions were not increased.Therefore, we conclude that the spectra optia cmnc protocol can be successfully modified for effective wbc and platelet depletions without increase in adverse reactions.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: SPECTRA 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: 20127828
• Report Number: 1722028-2024-00372
• Device Sequence Number: 20682276
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4123201
• 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: 12/11/2024; 12/26/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 12/23/2024; 12/26/2024
• 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