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

Catalog Number 12220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during the beginning of a therapeutic plasma exchange (tpe) it was noticed that the plasma was cherry red in the plasma line for the centrifuge and waste bag and they received a "cells detected in plasma line in centrifuge" alarm.The doctor at the customer site reported that it was ok to continue the run and they were able to complete it.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

H.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and associated aim images does not show a clear root cause for the reported occurrence of red tinged plasma in the remove line/bag suspected of hemolysis.In tpe the rbc detector is actively monitoring the color of the plasma line exiting the centrifuge to identify possible cell spillover or darker than expected plasma.If the fluid in the plasma line is detected to be darker than expected, an alarm is raised.In this case the plasma darkness was enough to raise the alarm ¿cells were detected in plasma line from centrifuge¿.The operator disabled the rbc detector after the occurrence of this alarm in order to continue the procedure without the recurrence of this alarm.Analysis of the rdf is not able to confirm the occurrence of hemolysis during this procedure.Early in the procedure, the cell interface remained low in the channel connector raising the alarm ¿aim system could not raise interface to correct position¿.This alarm is raised when the aim system detects the cell separation interface remains too low in the channel connector for 120 seconds.This may be caused if the patient hematocrit entered was too high, if the channel was not correctly loaded, or if the saline lines were not completely closed.To respond to this alarm, the operator should ensure the saline roller clamps at the inlet and return line are completely closed.In addition, the operator should look through the viewport to see the position of the rbc interface.If the interface is too low, the operator should consider decreasing the hct by 3% up to three times for a maximum decrease of 9% to raise the interface.In addition, the operator should consider checking that the centrifuge channel is correctly loaded by touching the stop button and waiting to open the centrifuge until it comes to a complete stop and the centrifuge unlock click sound is heard.Dlog analysis shows this alarm occurred 2x during this procedure.The operator did lower the patient hct by 3% at roughly 66 minutes into the procedure, following the second occurrence of this alarm.Review of the run data file showed the system to be operating as intended with the proper alarms raised.Medical safety concluded that based on the limited clinical and investigation findings of this report, the spectra optia device and tubing set performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors that contributed to or caused the death of the patient in this report.The customer confirmed that hemolysis was seen at the beginning of the procedure in the channel connector and waste bag.Acd-a and ns (normal saline) were correctly attached to the disposable set.There was no clotting observed in the channel or associated lines.No medical intervention was administered to the patient.No custom prime was performed.Clinical support followed up with the customer with questions about the suspected hemolysis during the procedure and was informed by the customer that the patient died several days later.The customer indicated the patient also had covid and was described as being 'too far gone'.The customer did verify the patient death occurred within 72 hours of patient treatment on the optia device.Despite several additional follow up attempts to get further clarification on the cause of patient death, the customer declined to respond.A device service check was made following this incident, the device autotests were successfully performed, indicating the device was functioning correctly.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during the beginning of a therapeutic plasma exchange (tpe) it was noticed that the plasma was cherry red in the plasma line for the centrifuge and waste bag and they received a "cells detected in plasma line in centrifuge" alarm.The doctor at the customer site reported that it was ok to continue the run and they were able to complete it.The customer reported that the patient later died.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10 (h.11).Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and associated aim images does not show a clear root cause for the reported occurrence of red tinged plasma in the remove line/bag suspected of hemolysis.In tpe the rbc detector is actively monitoring the color of the plasma line exiting the centrifuge to identify possible cell spillover or darker than expected plasma.If the fluid in the plasma line is detected to be darker than expected, an alarm is raised.In this case the plasma darkness was enough to raise the alarm ¿cells were detected in plasma line from centrifuge¿.The operator disabled the rbc detector after the occurrence of this alarm in order to continue the procedure without the recurrence of this alarm.Analysis of the rdf is not able to confirm the occurrence of hemolysis during this procedure.Early in the procedure, the cell interface remained low in the channel connector raising the alarm ¿aim system could not raise interface to correct position¿.This alarm is raised when the aim system detects the cell separation interface remains too low in the channel connector for 120 seconds.This may be caused if the patient hematocrit entered was too high, if the channel was not correctly loaded, or if the saline lines were not completely closed.To respond to this alarm, the operator should ensure the saline roller clamps at the inlet and return line are completely closed.In addition, the operator should look through the viewport to see the position of the rbc interface.If the interface is too low, the operator should consider decreasing the hct by 3% up to three times for a maximum decrease of 9% to raise the interface.In addition, the operator should consider checking that the centrifuge channel is correctly loaded by touching the stop button and waiting to open the centrifuge until it comes to a complete stop and the centrifuge unlock click sound is heard.Dlog analysis shows this alarm occurred 2x during this procedure.The operator did lower the patient hct by 3% at roughly 66 minutes into the procedure, following the second occurrence of this alarm.Review of the run data file showed the system to be operating as intended with the proper alarms raised.The customer confirmed that hemolysis was seen at the beginning of the procedure in the channel connector and waste bag.Acd-a and ns (normal saline) were correctly attached to the disposable set.There was no clotting observed in the channel or associated lines.No medical intervention was administered to the patient.No custom prime was performed.Clinical support followed up with the customer with questions about the suspected hemolysis during the procedure and was informed by the customer that the patient died several days later.The customer indicated the patient also had covid and was described as being 'too far gone'.The customer did verify the patient death occurred within 72 hours of patient treatment on the optia device.Despite several additional follow up attempts to get further clarification on the cause of patient death, the customer declined to respond.A device service check was made following this incident, the device autotests were successfully performed, indicating the device was functioning correctly.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient's underlying disease state * patient's medication and/or medical treatment * hemolysis due to inlet/return needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line * hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line * an occlusion within the tubing kit.

Event Description

The customer reported to terumo bct customer support that during the beginning of a therapeutic plasma exchange (tpe) hemolysis was noted in the plasma line for the centrifuge and waste bag and they received a "cells detected in plasma line in centrifuge" alarm.The customer described the plasma as cherry red and reported the patient experienced bleeding.The physician said it was ok to continue the run.Terumo bct clinical support instructed the physician through how to continue the run.The customer confirmed that hemolysis was seen at the beginning of the procedure in the channel connector and waste bag.Acd-a and ns (normal saline) were correctly attached to the disposable set.There was no clotting observed in the channel or associated lines.No medical intervention was administered to the patient.No custom prime was performed.The customer reported that the patient later died.The collection set is not available for return because it was discarded by the customer.

• 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: 17996293
• MDR Text Key: 326389335
• Report Number: 1722028-2023-00349
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 88 KG