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

Model Number	10110
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer reported that during four mononuclear cell collection procedures on four different devices, the device couldn¿t establish interface for a long time and kept alarming for the same reason.Per the customer, they kept lowering the hematocrit by 3% until reaching 21% to be able to start collection.The patient's cbc on the 3rd day results were hematocrit:34.1, hemoglobin: 10.7, wbc 55.410^6 & platelet: 12310^3.Per the customer, the patient did not have hyperviscous blood, but does have elevated immunoglobulin.Per the customer, for two consecutive days a lot of air was found in the line and the operator made sure that the line were secured and tight and there were no loading issues.Per the customer, medical intervention was necessary, however details of the medical intervention are not available at this time.Patient identifier and age are not available at this time.The set is not available for evaluation.
Event or Problem Description
The customer reported that during four mononuclear cell collection procedures on four different devices, the device couldn't establish interface for a long time and kept alarming for the same reason.Per the customer, they kept lowering the hematocrit by 3% until reaching 21% to be able to start collection.The patient's cbc on the 3rd day results were hematocrit:34.1, hemoglobin: 10.7, wbc 55.410^6 & platelet: 12310^3.Per the customer, the patient did not have hyperviscous blood, but does have elevated immunoglobulin.Per the customer, for two consecutive days a lot of air was found in the line and the operator made sure that the line were secured and tight and there were no loading issues.Per the customer, medical intervention was necessary, however details of the medical intervention are not available at this time.Patient identifier and age are not available at this time.The set is not available for evaluation.
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf associated with this complaint confirm the occurrence of the ¿interface took too long to establish¿ alarm numerous times during the procedures.In mnc procedures, this alarm is most often caused by an incorrect patient hematocrit entered to the machine.It is also possible that this alarm rises from an obstructed collect or plasma line or an incorrectly loaded channel.The operator correctly lowered the patient hematocrit in the procedures analyzed.In some procedures, the alarm persisted until the ¿air was detected in return line¿ alarm was generated.The operator then followed the machine instructions to clear the air from the return line.No clear root cause for the air being introduced to the return line was found.During air removal from the return line the optia will pull saline from the return saline bag to push the air back to the reservoir.The air will then escape to the vent bag and the return line will be cleared of air.Since fluid is pushed to the reservoir to clear the air, the reservoir will begin to accumulate fluid.When the operator was following the instructions for air removal on the second procedure analyzed above, the optia was not able to detect the clamp on the return line was closed and it raised the alarm ¿return line was not clamped during air removal¿.The system checks that the return line is clamped by using the pressure sensor.Possible causes for this alarm are if the return line was not clamped or if the return saline line was not completely closed.The operator pressed the ¿retry¿ button 3 times to detect the that the return line is clamped.After each retry the return pump kept introducing fluid to the reservoir.When the reservoir filled up the alarm ¿reservoir was full during air removal¿ was raised.This alarm only gives the option to unload the set and disconnect the patient.The operator followed the prompts on the screen and was able to disconnect the patient and remove the disposable.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer reported that during four mononuclear cell collection procedures on four different devices, the device couldn't establish interface for a long time and kept alarming for the same reason.Per the customer, they kept lowering the hematocrit by 3% until reaching 21% to be able to start collection.The patient's cbc on the 3rd day results were hematocrit: 34.1, hemoglobin: 10.7, wbc 55.410^6 & platelet: 12310^3.Per the customer, the patient did not have hyperviscous blood, but does have elevated immunoglobulin.Per the customer, for two consecutive days a lot of air was found in the line and the operator made sure that the line were secured and tight and there were no loading issues.Per the customer, medical intervention was necessary, however details of the medical intervention are not available at this time.Patient identifier and age are not available at this time.The set is not available for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf associated with this complaint confirm the occurrence of the ¿interface took too long to establish¿ alarm numerous times during the procedures.In mnc procedures, this alarm is most often caused by an incorrect patient hematocrit entered to the machine.It is also possible that this alarm rises from an obstructed collect or plasma line or an incorrectly loaded channel.The operator correctly lowered the patient hematocrit in the procedures analyzed.In some procedures, the alarm persisted until the ¿air was detected in return line¿ alarm was generated.The operator then followed the machine instructions to clear the air from the return line.No clear root cause for the air being introduced to the return line was found.During air removal from the return line the optia will pull saline from the return saline bag to push the air back to the reservoir.The air will then escape to the vent bag and the return line will be cleared of air.Since fluid is pushed to the reservoir to clear the air, the reservoir will begin to accumulate fluid.When the operator was following the instructions for air removal on the second procedure analyzed above, the optia was not able to detect the clamp on the return line was closed and it raised the alarm ¿return line was not clamped during air removal¿.The system checks that the return line is clamped by using the pressure sensor.Possible causes for this alarm are if the return line was not clamped or if the return saline line was not completely closed.The operator pressed the ¿retry¿ button 3 times to detect the that the return line is clamped.After each retry the return pump kept introducing fluid to the reservoir.When the reservoir filled up the alarm ¿reservoir was full during air removal¿ was raised.This alarm only gives the option to unload the set and disconnect the patient.The operator followed the prompts on the screen and was able to disconnect the patient and remove the disposable.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 h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf associated with this complaint confirm the occurrence of the ¿interface took too long to establish¿ alarm numerous times during the procedures.In mnc procedures, this alarm is most often caused by an incorrect patient hematocrit entered to the machine.It is also possible that this alarm rises from an obstructed collect or plasma line or an incorrectly loaded channel.The operator correctly lowered the patient hematocrit in the procedures analyzed.In some procedures, the alarm persisted until the ¿air was detected in return line¿ alarm was generated.The operator then followed the machine instructions to clear the air from the return line.No clear root cause for the air being introduced to the return line was found.During air removal from the return line the optia will pull saline from the return saline bag to push the air back to the reservoir.The air will then escape to the vent bag and the return line will be cleared of air.Since fluid is pushed to the reservoir to clear the air, the reservoir will begin to accumulate fluid.When the operator was following the instructions for air removal on the second procedure analyzed above, the optia was not able to detect the clamp on the return line was closed and it raised the alarm ¿return line was not clamped during air removal¿.The system checks that the return line is clamped by using the pressure sensor.Possible causes for this alarm are if the return line was not clamped or if the return saline line was not completely closed.The operator pressed the ¿retry¿ button 3 times to detect the that the return line is clamped.After each retry the return pump kept introducing fluid to the reservoir.When the reservoir filled up the alarm ¿reservoir was full during air removal¿ was raised.This alarm only gives the option to unload the set and disconnect the patient.The operator followed the prompts on the screen and was able to disconnect the patient and remove the disposable.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for the air could not be determined but it is likely due to one or a combination of the possible causes listed below: * operator failed to tighten the luer on the return line blood warmer connect and hangs the loose connection high allowing air to be drawn into the line.* a disposables defect which may cause low level sensor to report fluid instead of air resulting in air pumping towards the donor.* a disposables defect, clot, or debris that occludes the return filter resulting in a vacuum between the filter and the return pump header.* poor connection to the blood warmer due to excess solvent at the luer causing air to enter the return line.Based on the available information a definitive root cause for the low volume could not be determined but it is likely due to one or a combination of the possible causes listed below: * incorrect hct entered.* air block.* patient's blood physiology interferes with separation of cellular components and chamber triggering.* incorrect setting of collection preference.* platelet clumping which can interfere with proper separation of cells in the connector and/or chamber and can also cause system to repeatedly re-establish the interface.
Event or Problem Description
The customer reported that during four mononuclear cell collection procedures on four different devices, the device couldn¿t establish interface for a long time and kept alarming for the same reason.Per the customer, they kept lowering the hematocrit by 3% until reaching 21% to be able to start collection.The patient's cbc on the 3rd day results were hematocrit:34.1, hemoglobin: 10.7, wbc 55.410^6 & platelet: 12310^3.Per the customer, the patient did not have hyperviscous blood, but does have elevated immunoglobulin.Per the customer, for two consecutive days a lot of air was found in the line and the operator made sure that the line were secured and tight and there were no loading issues.Per the customer, medical intervention was necessary, however details of the medical intervention are not available at this time.Patient identifier and age are not available.The set is not available for evaluation.

• 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: 15537335
• Report Number: 1722028-2022-00325
• Device Sequence Number: 5178150
• Product Code: LKN
• UDI-Device Identifier: 05020583101104
• UDI-Public: 05020583101104
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: BK150251
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 02/01/2023
• Device Model Number: 10110
• Device Catalogue Number: 10110
• Device Lot Number: 2102223130
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 01/05/2023; 05/24/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/21/2022; 01/09/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 90 KG