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

Catalog Number	4103101
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fever (1858); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Chills (2191)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Null.
Event or Problem Description
The customer reported that a patient underwent a continuous multinuclear cell collection (cmnc) procedure with albumin priming.Mid procedure, the patient had one fever spike with chills, associated with tachycardia and hypotension.An ivf normal saline (ns) bolus and iv ceftriaxone was given.The patient developed a high grade fever and had multiple episodes of vomiting.Tachycardia and hypotension persisted and the ivf bolus was repeated.Blood workup indicated rising procalcitonin (>100), antibiotics were upgraded to iv meropenem and amikacin.Due to a fluid refractory shock, the patient was started on inj nor-adrenaline infusion.Repeat labs showed hb 7 and platelet 35000, so a packed red blood cell (prbc) transfusion was given.The procedure was terminated early.Electrolyte correction was given as per reports.Nor-adrenaline infusion was gradually tapered and stopped on 12/31/2025.Current patient status is "alive".Full patient id: (b)(6) the collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that a patient underwent a continuous multinuclear cell collection (cmnc) procedure with albumin priming.Mid procedure, the patient had one fever spike with chills, associated with tachycardia and hypotension.An ivf normal saline (ns) bolus and iv ceftriaxone was given.The patient developed a high-grade fever and had multiple episodes of vomiting.Tachycardia and hypotension persisted and the ivf bolus was repeated.Blood workup indicated rising procalcitonin (>100), antibiotics were upgraded to iv meropenem and amikacin.Due to a fluid refractory shock, the patient was started on inj nor-adrenaline infusion.Repeat labs showed hb 7 and platelet 35000, so a packed red blood cell (prbc) transfusion was given.The procedure was terminated early.Electrolyte correction was given as per reports.Nor-adrenaline infusion was gradually tapered and stopped on (b)(6) 2025.Current patient status is "alive".Full patient id: (b)(6) 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 b.7, h.6, h.10 and h.11.Investgiation: the run data file (rdf) was analyzed for this event.Review of the dlog and aim images associated with this complaint did not show any issues throughout the procedure.The dlog and images were reviewed for alarms, clumping, and any unusual events that may have impacted the run or that could possibly affect the patient¿s condition.The images show a normal separation of the blood components and position of the interface in the connector.There were no significant issues or signals that indicate unexpected device behavior throughout the procedure.The operator ended the run without rinseback at 15:01, as expected with low tbv patient with custom prime.Review of the procedure showed that the device performed as expected.The manufacturer of the disposable sterile solutions used in combination with this procedure are not known.However, for tbct solutions, per an internal technical report, the devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in d.4, h.6 and h.11.Investgiation: the run data file (rdf) was analyzed for this event.Review of the dlog and aim images associated with this complaint did not show any issues throughout the procedure.The dlog and images were reviewed for alarms, clumping, and any unusual events that may have impacted the run or that could possibly affect the patient¿s condition.The images show a normal separation of the blood components and position of the interface in the connector.There were no significant issues or signals that indicate unexpected device behavior throughout the procedure.The operator ended the run without rinseback at 15:01, as expected with low tbv patient with custom prime.Review of the procedure showed that the device performed as expected.The manufacturer of the disposable sterile solutions used in combination with this procedure are not known.However, for tbct solutions, per an internal technical report, the devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: review of the dlog and aim images associated with this complaint did not show any issues throughout the procedure.The dlog and images were reviewed for alarms, clumping, and any unusual events that may have impacted the run or that could possibly affect the patient¿s condition.The images show a normal separation of the blood components and position of the interface in the connector.There were no significant issues or signals that indicate unexpected device behavior throughout the procedure.For the first procedure, the operator ended the run without rinseback at 15:01, as expected with low tbv patient with custom prime.For the second procedure, it was noted that the saline rinse was performed after the disposable set prime ¿ a volume of 248.72ml went through the cassette.The operator ended the run without rinseback at 12:23, as expected with low tbv patient with custom prime.Review of the procedure showed that the device performed as expected, and the optia system is safe to use.In relation to the rising crp and elevated pct, a root cause cannot be definitively determined.The medication (g-csf) commonly used to mobilize stem cells from the bone marrow into the peripheral blood naturally increases systemic levels of pro-inflammatory mediators (like interleukin-6 and oncostatin m), which in turn causes the liver to produce more crp.This is a common and expected side effect of the mobilization process itself for many donors.While stem cell collection is generally safe, the preparatory procedures, such as administration of granulocyte colony-stimulating factor (g-csf) or central venous catheter (cvc) insertion, can trigger these markers.The symptoms reported (elevated pct, fever, chills, hypothermia, tachycardia) are also suggestive of a potential systemic inflammatory reaction and/or an infection/sepsis.Therefore it cannot be ruled out that an underlying infection was also present at the time of harvesting as an up-trending c-reactive protein (crp) accompanied by elevated procalcitonin (pct) during a stem cell harvest or the immediate post-harvest period suggests a potential systemic inflammatory reaction or underlying infection.Possible causes for an infection include, but are not limited to: complications associated with prolonged use of catheter access.Patients' underlying disease diagnosis (immunocompromised host) and/or the infection was endogenous and originated from the patient.Aseptic technique.
Event or Problem Description
The customer reported that a patient underwent a continuous multinuclear cell collection (cmnc) procedure with albumin priming.Mid procedure, the patient had one fever spike with chills, associated with tachycardia and hypotension.An ivf normal saline (ns) bolus and iv ceftriaxone was given.The patient developed a high grade fever and had multiple episodes of vomiting.Tachycardia and hypotension persisted and the ivf bolus was repeated.Blood workup indicated rising procalcitonin (>100), antibiotics were upgraded to iv meropenem and amikacin.Due to a fluid refractory shock, the patient was started on inj nor-adrenaline infusion.Repeat labs showed hb 7 and platelet 35000, so a packed red blood cell (prbc) transfusion was given.The procedure was terminated early.Electrolyte correction was given as per reports.Nor-adrenaline infusion was gradually tapered and stopped on (b)(6) 2025.Current patient status is "alive".Full patient id: (b)(6).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: 24326943
• Report Number: 1722028-2026-00028
• Device Sequence Number: 21201230
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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: 4103101
• Device Lot Number: 2412166241
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/16/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/09/2026; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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: 12 YR
• Patient Sex: Female
• Patient Weight: 49 KG