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

Model Number	10310
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	Hypervolemia (2664)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the continuous mononuclear cell collection (cmnc) is still establishing interface after 25 min.The operator entered a hct of 36% from 1/12/23 and only checked the lines to make sure they were not obstructed.Customer support suggested to lower the hct down by 3% and wait 3-5 min.If the interface still wasn't about half of the connector it was suggested to lower the hct another 3%.The customer called back after adjusting the hct down by 8% and said the interface was still in the same position.A picture was sent and it was maybe about 1/4th of the connector.It was asked if the saline line roller clamps were open.The operator realized the red roller clamp was open and was on the 2nd 500 ml bag.The operator said she was checked off to do this procedure.Customer support explained she shouldn't have to change out the saline bag for the procedure.The hct has been diluted and this is why the interface has not come up.The operator reported there was about 50 mls left in the 2nd bag.It was estimated the 657 ml of ns used.Customer support suggested she lower hct down by 6% which is now at 22%.Patient information and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer did not respond to multiple requests for lot number.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Retraining was not completed since the customer failed to respond to multiple attempts to contact them.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime divert.
Event or Problem Description
The customer reported the continuous mononuclear cell collection (cmnc) is still establishing interface after 25 min.The operator entered a hct of 36% from 1/12/23 and only checked the lines to make sure they were not obstructed.Customer support suggested to lower the hct down by 3% and wait 3-5 min.If the interface still wasn't about half of the connector it was suggested to lower the hct another 3%.The customer called back after adjusting the hct down by 8% and said the interface was still in the same position.A picture was sent and it was maybe about 1/4th of the connector.It was asked if the saline line roller clamps were open.The operator realized the red roller clamp was open and was on the 2nd 500 ml bag.The operator said she was checked off to do this procedure.Customer support explained she shouldn't have to change out the saline bag for the procedure.The hct has been diluted and this is why the interface has not come up.The operator reported there was about 50 mls left in the 2nd bag.It was estimated the 657 ml of ns used.Customer support suggested she lower hct down by 6% which is now at 22%.After multiple follow-up attempts, the customer did not provide patient information and outcome.The collection set is not available for return because it was discarded by the customer.

• 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: 16437280
• Report Number: 1722028-2023-00080
• Device Sequence Number: 3126510
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK150251
• 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): 02/24/2023

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 Model Number: 10310
• Device Catalogue Number: 10310
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/08/2024
• 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: Unknown