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

Catalog 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	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation: calculate final fluid balance (including saline bolus): 123%.Patient final fluid balance displayed by the system: 116%.The customer reported that they have initiated an internal capa to evaluate the event.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported to terumo bct customer support that during a continuous mononuclear cell collection (cmnc) procedure they were having problems stabilizing the interface.The customer lowered the hct and ac ratio and then noticed that the red saline roller clamp was open and the normal saline bag was empty.She replaced the bag, but was still unable to establish the interface.The customer reported that the hct was 38 and the interface was at 1/4, so customer support suggested she lower the hct to 32 and after a few minutes the interface was in the correct position.There were cells in the collect port so customer support provided instructions on how to continue with the run by adjusting the cp and opening the collect valve when they reached the desired color.Donor voiced not complaints, exhibited no adverse reactions.Donor remained baseline throughout the procedure.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: calculate final fluid balance (including saline bolus): 123%.Patient final fluid balance displayed by the system: 116%.The customer reported that they have initiated an internal capa to evaluate the event.A disposable lot history search indicated there were no other reported occurrences of open inlet saline roller clamp on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: terumo bct clinical specialist reminded the customer to check and make sure that the saline roller clamps were closed.The customer verified and acknowledged that the inlet saline roller clamp was inadvertently left open.In a subsequent follow-up, the customer declined the offer of retraining.Root cause: a root cause assessment was performed for the unintended saline bolus to the donor.Based on the customer's statements, she failed to follow the screen prompt to fully close the inlet saline roller clamp at the end of prime divert.
Event or Problem Description
The customer reported to terumo bct customer support that during a continuous mononuclear cell collection (cmnc) procedure they were having problems stabilizing the interface.The customer lowered the hct and ac ratio and then noticed that the red saline roller clamp was open and the normal saline bag was empty.She replaced the bag, but was still unable to establish the interface.The customer reported that the hct was 38 and the interface was at 1/4, so customer support suggested she lower the hct to 32 and after a few minutes the interface was in the correct position.There were cells in the collect port so customer support provided instructions on how to continue with the run by adjusting the cp and opening the collect valve when they reached the desired color.Donor voiced not complaints, exhibited no adverse reactions.Donor remained baseline throughout the procedure.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: 18013220
• Report Number: 1722028-2023-00354
• Device Sequence Number: 7548634
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Catalogue Number: 10310
• Device Lot Number: 2305096141
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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 Age: 26 YR
• Patient Sex: Female