MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number	61000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: preventative maintenace (pm) was completed on the machine at the customer site.Firstaccumulatedvolumelowalarm and finalaccumulatedvolumelowalarm were confirmed to have occurred during run, same as the reported condition.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer reported that during a continuous mononuclear cell collection (cmnc) procedure, they received the alarms 'patient's fluid balance may be 10% lower than reported' and 'patient's fluid balance may be 30% lower than reported.' patient information and outcome are not available at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in e.1 and e.3.
Additional Manufacturer Narrative
Root cause: review of the dlog did not indicate a conclusive root cause for the multiple ¿patient¿s fluid balance may be lower than reported¿ alarms which occurred during the procedure.After the third and final ¿patient¿s fluid balance may be 30% lower than reported¿ alarm was generated the run was ended by the system.Review of the images shows the interface was very high in the channel around the same time the reservoir accumulation began which led to the fluid balance alarms.This likely indicates there may have been an occlusion in the inlet line limiting the amount of fluid entering the set.The fluid balance alarms occur if the system detects a discrepancy with how much fluid should be in the reservoir and how much the pumps are contributing.Typical causes for this alarm can include an obstruction in the inlet line, collect line above or below the cassette, normal variation in pump stroke volume or the reservoir sensor failed.After the fluid balance alarm, the operator did not open the centrifuge door per the alarm screen instructions to check for proper loading of the kit.Review of the aim images for this procedure did indicate the interface was high in the channel around the same time the alarms began to generate.The inlet pressure sensor signals also changed around the same time likely indicating there was a restriction/occlusion in the inlet line after the inlet pressure sensor.This could have been caused by clumping in the inlet line trap leading to less fluid entering the system causing the interface to rise and the fluid balance alarms.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.The initial inlet:ac ratio was set to 12 and remained there for the entirety of the procedure.
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.Dlog analysis states ending fluid balance was 110% and the customer did not report or allege an adverse event occurred.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no issues related to the reported condition identified.The run data file was analyzed for this event.Review of the rdf did not indicate a conclusive root cause for the multiple ¿patient¿s fluid balance may be lower than reported¿ alarms which occurred during the procedure.After the third and final ¿patient¿s fluid balance may be 30% lower than reported¿ alarm was generated the run was ended by the system.Review of the images shows the interface was very high in the channel around the same time the reservoir accumulation began which led to the fluid balance alarms.This likely indicates there may have been an occlusion in the inlet line limiting the amount of fluid entering the set.The fluid balance alarms occur if the system detects a discrepancy with how much fluid should be in the reservoir and how much the pumps are contributing.Typical causes for this alarm can include an obstruction in the inlet line, collect line above or below the cassette, normal variation in pump stroke volume or the reservoir sensor failed.After the fluid balance alarm, the operator did not open the centrifuge door per the alarm screen instructions to check for proper loading of the set.Review of the aim images for this procedure did indicate the interface was high in the channel around the same time the alarms began to generate.The inlet pressure sensor signals also changed around the same time likely indicating there was a restriction/occlusion in the inlet line after the inlet pressure sensor.This could have been caused by clumping in the inlet line trap leading to less fluid entering the system causing the interface to rise and the fluid balance alarms.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.The initial inlet: ac ratio was set to 12 and remained there for the entirety of the procedure.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The patient's gender and weight were obtained from the run data file; the patient's id and age are unknown.The customer did not respond to attempts for patient information.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11349340
• Report Number: 1722028-2021-00076
• Device Sequence Number: 14296288
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/19/2021

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 Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/25/2021; 04/14/2021; 06/30/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 04/06/2021; 04/30/2021; 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 10