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

Catalog Number	4103101
Medical Device Problem Codes	Human-Device Interface Problem (2949); Inadequate User Interface (2958); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypervolemia (2664)
Date of Event	07/22/2023
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 to terumo bct customer support that after connecting the patient, they confirmed that the saline roll clamp on the return line was held during the procedure, but the saline continued to enter.Patient information and outcome are unknown at this time.Terumo bct is awaiting return of the disposable set for evaluation.
Additional Manufacturer Narrative
Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.The set was received with both saline roller clamps closed.The clamps were confirmed properly occluding the saline lines.The cassette was checked for warping that would prevent the valves from properly occluding the tubing lines and no excessive warping was found that would lead to valves not occluding the tubing.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed, on 04 june 2024, for this lot and found no reports for similar issues on this lot worldwide.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the evaluation of the returned disposable set, the operator failed to follow the screen prompts to fully close the return saline roller clamp at the end of saline prime divert.
Event or Problem Description
The customer reported to terumo bct customer support that after connecting the patient, they confirmed that the saline roll clamp on the return line was held during the procedure, but the saline continued to enter.Patient information and outcome are unknown.Multiple attempts were made to obtain essential information but the customer was unable to provide any additional information.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL 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: 17565086
• Report Number: 1722028-2023-00280
• Device Sequence Number: 6966854
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 08/17/2023

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: 03/01/2025
• Device Catalogue Number: 4103101
• Device Lot Number: 2303023141
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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