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

Catalog Number	4123201
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Dizziness (2194)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: 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 15 minutes into a continuous mononuclear cell collection (cmnc) on a spectra optia device, the operator failed to make a complete seal in the sample pouch by the inlet site.Per the customer, the operator observed air going into the inlet line (luer connector) and centrifuge, and the operator believed air was going directly into the return line.It was reported that there were no alarms regarding the return line.The patient quickly complained of shortness of breath and dizziness.The patient was put on oxygen (o2), positioned on their left side, and the nurse practitioner (np) ordered a transfer to the emergency room (er).All leur connections were tight and there was no clotting in the channel or in the return reservoir.Stopcock with calcium gluconate iv line was connected to the return line at the time of the event.Patient outcome is unknown at this time.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in d.4, g.4, h.6 and h.11.Investigation: the return line was connected to a stopcock for administration of iv calcium gluconat.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 for this lot and found no reports for similar issues on this lot worldwide.Correction: terumo bct clinical specialist explained to the operator how air would have been vented as a result of a partially sealed blood diversion bag at the time of the call.Root cause: a root cause assessment was performed for air in the inlet line.The root cause was due to a partially sealed blood diversion bag.There was no potential of air being returned to the patient.The medical intervention was administered as a precaution.
Event or Problem Description
The customer reported that 15 minutes into a continuous mononuclear cell collection (cmnc) on a spectra optia device, the operator failed to make a complete seal in the sample pouch by the inlet site.Per the customer, the operator observed air going into the inlet line (luer connector) and centrifuge, and the operator believed air was going directly into the return line.It was reported that there were no alarms regarding the return line.The patient quickly complained of shortness of breath and dizziness.The patient was put on oxygen (o2), positioned on their left side, and the nurse practitioner (np) ordered a transfer to the emergency room (er).All leur connections were tight and there was no clotting in the channel or in the return reservoir.Stopcock with calcium gluconate iv line was connected to the return line at the time of the event.Patient outcome is unknown at this time.The platelet 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: 20101122
• Report Number: 1722028-2024-00364
• Device Sequence Number: 8442422
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 03/01/2026
• Device Catalogue Number: 4123201
• Device Lot Number: 2403073141
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG