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

Catalog Number	4123201
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Itching Sensation (1943); Rash (2033); Hot Flashes/Flushes (2153); Urticaria (2278)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
Customer reported an allergic reaction during a continuous mononuclear cell collection (cmn) on spectra optia device, that the customer believed was related to ethylene oxide (eto).Per the customer, the patient broke out in hives on their ears, neck, stomach, and legs and also became flush.It was reported that the patient was given benadryl, as well as other medication, and then complained of 10/10 abdominal pain and was transported to the hospital via emergency medical services (ems).It was noted that the patient donated 3 years earlier with no known issues.The patient's condition was reported as "discharged home".The nurse stated that the ac infusion rate was 0-1.2.The procedure started at 7:52, was paused at 8:58, and no rinseback was given.The type of anticoagulant used/concentration of solution was acid-citrate-dextrose formula a (acda) 750 ml bag with 0.9 ml heparin 5000 unit/ml, and all solutions were correctly attached.The reported total amount of ac delivered was 278 ml, and the reported total amount of ac delivered was not greater than what was reported by the device.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
Customer reported an allergic reaction during a continuous mononuclear cell collection (cmn) on spectra optia device, that the customer believed was related to ethylene oxide (eto).Per the customer, the patient broke out in hives on their ears, neck, stomach, and legs and also became flush.It was reported that the patient was given benadryl, as well as other medication, and then complained of 10/10 abdominal pain and was transported to the hospital via emergency medical services (ems).It was noted that the patient donated 3 years earlier with no known issues.The patient's condition was reported as "discharged home".The nurse stated that the ac infusion rate was 0-1.2.The procedure started at 7:52, was paused at 8:58, and no rinseback was given.The type of anticoagulant used/concentration of solution was acid-citrate-dextrose formula a (acda) 750 ml bag with 0.9 ml heparin 5000 unit/ml, and all solutions were correctly attached.The reported total amount of ac delivered was 278 ml, and the reported total amount of ac delivered was not greater than what was reported by the device.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 d.1, h.6 and h.11.Investigation: this product has been processed with eto to achieve a 10-6 sterility assurance level in accordance with en iso 11135.This product has been validated to achieve less than 6mg eto, meeting the requirements of iso 10993-7 prior to release and less then 1ppm in the collect bag at time of use.All sterilization requirements passed.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Root cause: a root cause assessment was performed for the allergic reactions.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.* hypersensitivity to the components inside the disposable set.

• 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: 21774173
• Report Number: 1722028-2025-00081
• Device Sequence Number: 8263639
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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
• Device Lot Number: 2410173241
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White