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

Catalog Number	10310
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Tachycardia (2095)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Review of rdf shows there were 3 'interface took too long to establish' alarms.At 10min, 20 min and 142min.The procedure was able to establish an interface and seemed to operate normally.The images during the procedure also appeared normal.Follow on screen instructions for dealing with interface alarms.Machine operated as expected.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during a continuous mononuclear cell (cmnc) collection on a spectra optia device, they had problems establishing the interface.Per the customer there were no alarms.The customer changed out the 1 liter normal saline (ns) bag two times.Per the operator the red and blue roller clamps were closed.The procedure was ended with the patient receiving rinse back and using another machine for the procedure.The customer reported that the patient had hypertension, tachycardia and complained of shortness of breath.Per the locations doctor, the patient was given amlodopine 5 mg po, x 2 doses.Per the customer the patient was reported as stable.The customer was not able to provide patient id and weight.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that during a continuous mononuclear cell (cmnc) collection on a spectra optia device, they had problems establishing the interface.Per the customer there were no alarms.The customer changed out the 1 liter normal saline (ns) bag two times.Per the operator the red and blue roller clamps were closed.The procedure was ended with the patient receiving rinse back and using another machine for the procedure.The customer reported that the patient had hypertension, tachycardia and complained of shortness of breath.Per the locations doctor, the patient was given amlodopine 5 mg po, x 2 doses.Per the customer the patient was reported as stable.The customer was not able to provide patient id and weight.Multiple attempts were made to obtain the patients weight and lot number but the customer failed to respond.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 b.5, h6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of rdf shows there were 3 'interface took too long to establish' alarms.At 10 min, 20 min and 142 min.The interface took too long to establish alarm can occur for several reasons.In this case, it is possible that leaving the inlet saline roller clamp open or partially open may explain this alarm.If more saline was used than the machine stated it is likely the inlet saline clamp was open or partially open, leading to more saline being used than expected.It may be possible that the inlet saline roller clamp was opened or partially open and therefore diluted what was entering the machine leading to the interface alarms that occurred.The procedure was able to establish an interface and seemed to operate normally.The images during the procedure also appeared normal.Follow on screen instructions for dealing with interface alarms.Machine operated as expected and is safe to use.A disposable lot history search could not be conducted since the customer failed to provide a disposable lot number.Dhr could not be assessed as the customer was unable to provide the lot number.All lots must meet acceptance criteria for 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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of rdf shows there were 3 'interface took too long to establish' alarms.At 10 min, 20 min and 142 min.The interface took too long to establish alarm can occur for several reasons.In this case, it is possible that leaving the inlet saline roller clamp open or partially open may explain this alarm.If more saline was used than the machine stated it is likely the inlet saline clamp was open or partially open, leading to more saline being used than expected.It may be possible that the inlet saline roller clamp was opened or partially open and therefore diluted what was entering the machine leading to the interface alarms that occurred.The procedure was able to establish an interface and seemed to operate normally.The images during the procedure also appeared normal.Follow on screen instructions for dealing with interface alarms.Machine operated as expected and is safe to use.A disposable lot history search could not be conducted since the customer failed to provide a disposable lot number.Dhr could not be assessed as the customer was unable to provide the lot number.All lots must meet acceptance criteria for 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 unintended saline bolus to the patient.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * defective saline roller clamp * failure to fully close the saline roller clamp a root cause assessment was performed for the hypertension, tachycardia and complained of shortness of breath.Based on the available information a definitive root cause could not be determined.These 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 reported that during a continuous mononuclear cell (cmnc) collection on a spectra optia device, they had problems establishing the interface.Per the customer there were no alarms.The customer changed out the 1 liter normal saline (ns) bag two times.Per the operator the red and blue roller clamps were closed.The procedure was ended with the patient receiving rinse back and using another machine for the procedure.The customer reported that the patient had hypertension, tachycardia and complained of shortness of breath.Per the locations doctor, the patient was given amlodopine 5 mg po, x 2 doses.Per the customer the patient was reported as stable.The customer was not able to provide patient id and weight.Multiple attempts were made to obtain the patient's weight and lot number but the customer failed to respond.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: 18184458
• Report Number: 1722028-2023-00390
• Device Sequence Number: 15375431
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/21/2023

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 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: 10/30/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 12/20/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/08/2024
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female