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

Catalog Number	10120
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	03/01/2024
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 machine priming on a spectra optia device, the machine displayed the error message "return air detector, test to verify liquid present in the return line failed".They were able to reload a new disposable set and continue the procedure.Upon review of the information by terumo bct it was noted that the incident date of the event was reported as 03/01/2024 and the set expired 08/01/2023.There was not a transfusion recipient or patient involved at the time of the event, therefore no patient information is reasonably known.Terumo bct is awaiting return of the disposable set for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: an unused spectra optia disposable set was received for investigation.The set was found to be assembled correctly with no kinks or missing parts.No disposable defects were identified.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.
Event or Problem Description
The customer reported that during machine priming on a spectra optia device, the machine displayed the error message "return air detector, test to verify liquid present in the return line failed".They were able to reload a new disposable set and continue the procedure.Upon review of the information by terumo bct it was noted that the incident date of the event was reported as (b)(6) 2024 and the set expired (b)(6) 2023.There was not a transfusion recipient or patient involved at the time of the event, therefore no patient information is reasonably known.Terumo bct is awaiting return of the disposable set for evaluation.
Additional Manufacturer Narrative
Investigation: an unused spectra optia disposable set was received for investigation.The set was found to be assembled correctly with no kinks or missing parts.No disposable defects were identified.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 there was no use of an expired set.No further reporting will be provided as this does not represent a reportable event. .
Event or Problem Description
The customer reported that during machine priming on a spectra optia device, the machine displayed the error message "return air detector, test to verify liquid present in the return line failed".They were able to reload a new disposable set and continue the procedure.Upon review of the information by terumo bct it was noted that the incident date of the event was reported as 03/01/2024 and the set expired 08/01/2023.There was not a transfusion recipient or patient involved at the time of the event, therefore no patient information is reasonably known.Terumo bct is awaiting return of the disposable set 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: 19061945
• Report Number: 1722028-2024-00132
• Device Sequence Number: 12236494
• Product Code: LKN
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/08/2024

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 Expiration Date: 08/01/2023
• Device Catalogue Number: 10120
• Device Lot Number: 2108313130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 06/05/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/02/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown