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

Catalog Number	4121201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during a continuous mononuclear cell collection (cmnc) on a spectra optia device, the reservoir became foamy, and the return pump was potentially defective.Per the customer, the device alarmed "foam in the reservoir".Medical intervention was reported, but it is unknown at this time was required.Patient information and outcome are unknown at this time.Terumo bct is awaiting return of the disposable set for evaluation.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
Investigation: one used optia set was received for investigation.Initial observation noted blood throughout the set with no kinks, misassemblies or leaks discovered.The witness mark on the lower hex was present in the correct place.No foam was observed in the reservoir.No clotting or clumping was observed.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) on a spectra optia device, the reservoir became foamy, and the return pump was potentially defective.Per the customer, the device alarmed "foam in the reservoir".Medical intervention was reported, but it is unknown at this time was required.Patient information and outcome are unknown at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: one used optia set was received for investigation.Initial observation noted blood throughout the set with no kinks, misassemblies or leaks discovered.The witness mark on the lower hex was present in the correct place.No foam was observed in the reservoir.No clotting or clumping was observed.It was confirmed that the customer marked the questionnaire in error and no injury and medical intervention occurred.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 customer marked the questionnaire in error and no injury and medical intervention occurred.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that during a continuous mononuclear cell collection (cmnc) on a spectra optia device, the reservoir became foamy, and the return pump was potentially defective.Per the customer, the device alarmed "foam in the reservoir".Medical intervention was reported, but it is unknown at this time was required.Patient information and outcome are unknown at this time.

• 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: 20334375
• Report Number: 1722028-2024-00420
• Device Sequence Number: 8097411
• Product Code: LKN
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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 Expiration Date: 02/01/2026
• Device Catalogue Number: 4121201
• Device Lot Number: 2402166141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 10/30/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/24/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: Other
• Patient Sex: Unknown