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

Model Number 12220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 04/16/2022

Event Type  Death  

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.Following the procedure, the patient was to be discharged.The patient's central venous catheter was removed.The patient expired 5-6 hours after the tpe procedure.Patient was alert and oriented x3 prior to the procedure.There were no adverse events noted during the procedure.The tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.Following the procedure, the patient was to be discharged.The patient's central venous catheter was removed.Respiratory decompensation occurred approximately 5 hours post-tpe and ~2 hr post-line removal.The patient was ultimately intubated and died ~10 hours post procedure due to bradycardia and cardiac arrest.Per the customer, stable post procedure.He coded shortly after removal of his central line, probably had an air embolus or clot thrown.There was no autopsy performed.Patient was alert and oriented x3 prior to the procedure.There were no adverse events noted during the procedure and the patient was given 10% calcium gluconate 1 gm during.The tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Manufacturer Narrative

This report is being filed to provide additional information in b.4, b.5, b.6, h.6 and h.10.Investigation: per the customer, the cause of death was "probably had an air embolus or clot thrown" investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.Following the procedure, the patient was to be discharged.The patient's central venous catheter was removed.Respiratory decompensation occurred approximately 5 hours post-tpe and ~2 hr post-line removal.The patient was ultimately intubated and died ~10 hours post procedure due to bradycardia and cardiac arrest.Per the customer, stable post procedure.He coded shortly after removal of his central line, probably had an air embolus or clot thrown.There was no autopsy performed.Patient was alert and oriented x3 prior to the procedure.There were no adverse events noted during the procedure and the patient was given 10% calcium gluconate 1 gm during.The tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Manufacturer Narrative

Investigation: per the customer, the cause of death was "probably had an air embolus or clot thrown" a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Signals in the rdf do not suggest any issues in the procedure that may have resulted in the adverse event.There were multiple ¿aim system did not detect interface¿ alarms that occurred during the procedure before the aim system was disabled by the operator.This alarm may occur if the system cannot identify the interface for various reasons including the channel was loaded incorrectly affecting the interface position, the entered patient hematocrit is too high or dirt was on the filler or connector.If the disposable kit was confirmed to be loaded correctly and the connector and filler are clean and free of debris, it is recommended to lower the entered patient¿s hematocrit by 3 points to help bring the interface up.The operator increased the patients hct from (b)(4) before disabling the aim system.This is the opposite of the recommendation to lower the hct and explains why the alarm did not go away.It is recommended to lower the patient¿s entered hematocrit.If the alarm continues to recur after lowering the hct, it is recommended to resume the procedure in semiautomatic mode or discontinue the procedure until the service technician can verify functionality of the aim camera system and lighting.The operator chose to disable the aim system and was able to complete the procedure.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, h.6 and h.10.Investigation: per the customer, the cause of death was "probably had an air embolus or clot thrown" a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Signals in the rdf do not suggest any issues in the procedure that may have resulted in the adverse event.There were multiple ¿aim system did not detect interface¿ alarms that occurred during the procedure before the aim system was disabled by the operator.This alarm may occur if the system cannot identify the interface for various reasons including the channel was loaded incorrectly affecting the interface position, the entered patient hematocrit is too high or dirt was on the filler or connector.If the disposable kit was confirmed to be loaded correctly and the connector and filler are clean and free of debris, it is recommended to lower the entered patient¿s hematocrit by 3 points to help bring the interface up.The operator increased the patients hct from 41% to 44% to 46% before disabling the aim system.This is the opposite of the recommendation to lower the hct and explains why the alarm did not go away.It is recommended to lower the patient¿s entered hematocrit.If the alarm continues to recur after lowering the hct, it is recommended to resume the procedure in semiautomatic mode or discontinue the procedure until the service technician can verify functionality of the aim camera system and lighting.The operator chose to disable the aim system and was able to complete the procedure.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.The customer declined to confirm who determined the cause of death.No autopsy was performed.The nurse consulted with their medical director and she concluded that "this was some sort of systemic inflammatory response syndrome/capillary leak syndrome due to the hemoconcentration." a service call was carried out on 10 may 2022.Completed functional check out of spectra optia including startup test, post start test and autotest.Completed aims system checkout.Based on the clinical and investigation findings of this report, the spectra optia device and exchange set performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any stated user errors that contributed to or caused the death of the patient in this report whose death was likely related to their underlying medical condition related to severe covid.Importantly, the patient¿s clinical condition appeared to be stable at the completion of their tpe procedure.The requirement of calcium gluconate during the procedure is a standard therapeutic intervention during tpe for low ionized calcium levels.Per terumo bct internal medical review the device did not cause or contribute to the reported death.A disposable complaint history search was performed for this lot and found one other report of patient death on this lot from the same customer site submitted in mdr # 1722028-2022-00170.Root cause: based on the information from the clinical and investigational findings, the cause of the patient's death was likely due to the pre-existing disease condition.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) procedure.Following the procedure, the patient was to be discharged.The patient's central venous catheter was removed.Respiratory decompensation occurred approximately 5 hours post-tpe and ~2 hr post-line removal.The patient was ultimately intubated and died ~10 hours post procedure due to bradycardia and cardiac arrest.Per the customer, stable post procedure.He coded shortly after removal of his central line, probably had an air embolus or clot thrown.There was no autopsy performed.Patient was alert and oriented x3 prior to the procedure.There were no adverse events noted during the procedure and the patient was given 10% calcium gluconate 1 gm during.This was discussed with neuro team, and that it was ok to proceed and fibrinogen cryoprecipitate was to be given post procedure.There were no adverse events noted during the procedure.The patient developed respiratory decompensation approximately 3 hours after the tpe procedure and 2 hours after the line removal.He coded shortly after removal of his central line and required intubation.The patient eventually developed bradycardia with cardiac arrest and died approximately 10 hours after completion of the tpe procedure.The last reported h/h and wbc were 21.7g/dl/66% and 76,000/ l although the timing of these labs relative to the patient¿s decompensation is not known.Cause of death was documented as most likely an air embolus or clot thrown as patient was covid positive.The patient was described as stable post procedure.The customer did not indicate if they suspected the device caused or contributed to the patient death.The customer declined to confirm who determined the cause of death.No autopsy was performed.The nurse consulted with their medical director and she concluded that "this was some sort of systemic inflammatory response syndrome/capillary leak syndrome due to the hemoconcentration." in addition, she was not sure why the hospital reported the cause of death as a result of air embolus/blood clot embolus the tpe set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 14517195
• MDR Text Key: 292785774
• Report Number: 1722028-2022-00169
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 201263130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/10/2022; 11/14/2022; 01/05/2023
• Supplement Dates FDA Received: 06/20/2022; 12/05/2022; 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10%CA GLUCONATE 1GM IV PROHYLAXIS; 10%CA GLUCONATE 1GM IV PROHYLAXIS; 10%CA GLUCONATE 1GM IV PROHYLAXIS; 10%CA GLUCONATE 1GM IV PROHYLAXIS
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 135 KG