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

Model Number	10310
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer called terumo bct customer support after pausing a platelet depletion procedure because the patient had a drop in blood pressure.The customer wanted to know if they could continue to use the disposable set.The customer said the patient received a bolus of normal saline because their blood pressure dropped.The patient was stable after, but the customer wanted to continue the run and didn't know if they could continue to use the disposable set.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
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 provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Root cause: a root cause assessment was performed for the hypotension.Based on the available information a definitive root cause could not be determined.Hypotension are common side effects of therapeutic apheresis procedures.They are typically caused by the patient's disease state, the rate of ac infusion, the length of the procedure, the patient's sensitivity to the procedure and/or the hemodynamic stress of the procedure.
Event or Problem Description
The customer called terumo bct customer support after pausing a platelet depletion procedure because the patient had a drop in blood pressure.The customer wanted to know if they could continue to use the disposable set.The customer said the patient received a bolus of normal saline because their blood pressure dropped.The patient was stable after, but the customer wanted to continue the run and didn't know if they could continue to use the disposable set.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer called terumo bct customer support after pausing a platelet depletion procedure because the patient had a drop in blood pressure.The customer wanted to know if they could continue to use the disposable set.The customer said the patient received a bolus of normal saline because their blood pressure dropped.The patient was stable after, but the customer wanted to continue the run and didn't know if they could continue to use the disposable set.Patient information and outcome are unknown at this time.The 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 h.10.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Investigation is in process, a follow-up report will be provided.

• 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: 17362141
• Report Number: 1722028-2023-00248
• Device Sequence Number: 6068246
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/20/2023

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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 09/08/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/07/2023; 09/12/2023
• 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 Sex: Unknown