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	Dehydration (1807); Headache (1880); Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number, manufacture date and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: wang, m.L., davenport, r.D., & yamada, c.(2015).Comparison of two leukocytapheresis protocols in a case of idiopathic hypereosinophilic syndrome.Journal of clinical apheresis, 31(5), 481¿489.Https://doi.Org/10.1002/jca.21435.
Event or Problem Description
Per journal article "comparison of two leukocytapheresis protocols in a case of idiopathic hypereosinophilic syndrome" by michael l.Wang, robertson d.Davenport, and chisa yamada background: hypereosinophilic syndrome (heos) is rare, and the efficacy of leukocytapheresis in this context is unclear.We here report the successful treatment of a patient with idiopathic heos with four leukocytapheresis procedures using two protocols.Case: a 4-year-old female presented with cardiac and respiratory dysfunction, and wbc of 225 k/ll with 96% eosinophils.Leukocytapheresis was started after initiation of methylprednisolone and hydroxyurea.She received two leukocytapheresis with polymorphonuclear cell (pmn) protocol, followed by initiation of imatinib therapy, then two leukocytapheresis with mononuclear cell (mnc) protocol.After the fourth leukocytapheresis, her wbc decreased to 69 k/ll with 82% eosinophils.She was discharged on hospital day 21 under stable condition with wbc of 22 k/ll with 86% eosinophils.Wbc count and eosinophil percentage continued to decrease, and were 6.4 k/ll and 52% by 2 weeks and 3.9 k/ll and 4.9% by 3 months after discharge, respectively.Findings: wbc and absolute eosinophil (aeo) counts decreased by an average of 29.0 and 30.4% per leukocytapheresis, respectively.Normalized to estimated blood volume, procedures with pmn and mnc protocols changed, on average, wbc by 210.7 and 212.1%, aeo by 210.4 and 213.4%, platelet by 28.1 and 219.2%, and fluid balance by 2129 and 247 ml, respectively.Conclusion: leukocytapheresis was effective in decreasing wbc and aeo counts in heos, with pmn and mnc protocols achieving similar reductions.However, pmn protocol resulted in greater negative fluid balance and mnc protocol resulted in greater platelet loss.Specific details, such as further patient information was 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.
Event or Problem Description
Per journal article "comparison of two leukocytapheresis protocols in a case of idiopathic hypereosinophilic syndrome" by michael l.Wang, robertson d.Davenport, and chisa yamada background: hypereosinophilic syndrome (heos) is rare, and the efficacy of leukocytapheresis in this context is unclear.We here report the successful treatment of a patient with idiopathic heos with four leukocytapheresis procedures using two protocols.Case: a 4-year-old female presented with cardiac and respiratory dysfunction, and wbc of 225 k/ll with 96% eosinophils.Leukocytapheresis was started after initiation of methylprednisolone and hydroxyurea.She received two leukocytapheresis with polymorphonuclear cell (pmn) protocol, followed by initiation of imatinib therapy, then two leukocytapheresis with mononuclear cell (mnc) protocol.After the fourth leukocytapheresis, her wbc decreased to 69 k/ll with 82% eosinophils.She was discharged on hospital day 21 under stable condition with wbc of 22 k/ll with 86% eosinophils.Wbc count and eosinophil percentage continued to decrease, and were 6.4 k/ll and 52% by 2 weeks and 3.9 k/ll and 4.9% by 3 months after discharge, respectively.Findings: wbc and absolute eosinophil (aeo) counts decreased by an average of 29.0 and 30.4% per leukocytapheresis, respectively.Normalized to estimated blood volume, procedures with pmn and mnc protocols changed, on average, wbc by 210.7 and 212.1%, aeo by 210.4 and 213.4%, platelet by 28.1 and 219.2%, and fluid balance by 2129 and 247 ml, respectively.Conclusion: leukocytapheresis was effective in decreasing wbc and aeo counts in heos, with pmn and mnc protocols achieving similar reductions.However, pmn protocol resulted in greater negative fluid balance and mnc protocol resulted in greater platelet loss.Specific details, such as further patient information was 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
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.No medical intervention was required and the procedure was considered successful.The patient went on to have another 2 rounds of leukapheresis and was discharged.No further reporting will be provided as this does not represent a reportable event.Citation: wang, m.L., davenport, r.D., & yamada, c.(2015).Comparison of two leukocytapheresis protocols in a case of idiopathic hypereosinophilic syndrome.Journal of clinical apheresis, 31(5), 481¿489.Https://doi.Org/10.1002/jca.21435.

• 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: 22885178
• Report Number: 1722028-2025-00193
• Device Sequence Number: 8790372
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/25/2025

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: 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: 08/01/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 02/27/2026
• 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: 4 YR
• Patient Sex: Female
• Patient Weight: 20 KG