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

Catalog Number	10220
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: manufacture and expiry date are not available at this time.The run data file (rdf) was analyzed for this event.Review of the run data files for the tpe procedure confirmed that the ¿aim system saw red blood cells near top of connector¿ alarm number 5512, was generated throughout the run causing the operator to eventually end the run early.It was confirmed that the patient had darker plasma due to liver disease that contributed to the events experienced during the procedure.The ¿aim system saw red blood cells near top of connector¿ alarm is generated when the red blood cell interface in the connector is higher than the system expects.In a tpe procedure, the aim system monitors the interface for proper cell separation and possible spillover events.In this software version, the ¿disable¿ button on the ¿aim system saw red blood cells near top of connector¿ alarm was removed to help prevent operators from accidentally pressing this button when this alarm occurs.Generally, there are other root causes that should be attempted first as once you disable the aim system you cannot go back.The option to go to the operation status tab, into semi-automatic mode is available however this mode will not disable spillover alarms such as this one.The operator made several attempts to enter semi-automatic mode and the alarms continued.Terumo bct is aware of this situation and is currently looking at options to address this in the future.Additionally, for tpe procedures the ¿cells were detected in plasma line from centrifuge¿ alarm generated by the rbc detector occurs most frequently in these types of dark plasma situations and the ¿disable¿ button is available.However, for this run, the patient¿s dark plasma was consistently just below the trigger value, so this alarm was not generated during the run.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a therapeutic plasma exchange (tpe) on a spectra optia device, the system displayed the error message "aim system saw red blood cells near top of connector".The operator reported that the plasma was dark due to the patient's liver failure.Per the customer, the device error message did not have the option to disable the aim system, and the operator terminated the procedure.Patient id, age and outcome are unknown at this time.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 h.6 and h.11.Investigation: manufacture and expiry date are not available at this time.The run data file (rdf) was analyzed for this event.Review of the run data files for the tpe procedure confirmed that the ¿aim system saw red blood cells near top of connector¿ alarm number 5512, was generated throughout the run causing the operator to eventually end the run early.It was confirmed that the patient had darker plasma due to liver disease that contributed to the events experienced during the procedure.The ¿aim system saw red blood cells near top of connector¿ alarm is generated when the red blood cell interface in the connector is higher than the system expects.In a tpe procedure, the aim system monitors the interface for proper cell separation and possible spillover events.In this software version, the ¿disable¿ button on the ¿aim system saw red blood cells near top of connector¿ alarm was removed to help prevent operators from accidentally pressing this button when this alarm occurs.Generally, there are other root causes that should be attempted first as once you disable the aim system you cannot go back.The option to go to the operation status tab, into semi-automatic mode is available however this mode will not disable spillover alarms such as this one.The operator made several attempts to enter semi-automatic mode and the alarms continued.Terumo bct is aware of this situation and is currently looking at options to address this in the future.Additionally, for tpe procedures the ¿cells were detected in plasma line from centrifuge¿ alarm generated by the rbc detector occurs most frequently in these types of dark plasma situations and the ¿disable¿ button is available.However, for this run, the patient¿s dark plasma was consistently just below the trigger value, so this alarm was not generated during the run.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.It was confirmed that the hemolysis was related to the patient disease state and not the tbct device.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that during a therapeutic plasma exchange (tpe) on a spectra optia device, the system displayed the error message "aim system saw red blood cells near top of connector".The operator reported that the plasma was dark due to the patient's liver failure.Per the customer, the device error message did not have the option to disable the aim system, and the operator terminated the procedure.Patient id, age and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA EXCHANGE 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: 20043640
• Report Number: 1722028-2024-00348
• Device Sequence Number: 20807368
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• 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
• Report Date (Section B): 08/22/2024

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: 10220
• Device Lot Number: 2311013144
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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 Sex: Male
• Patient Weight: 67 KG