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

Catalog Number 4122201

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

Patient Problem Insufficient Information (4580)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.In total 5 d log files spanning 2 separate tpe procedures performed on the same patient were reviewed in this analysis.In the first procedure summarized above, there were 2 occurrences of alarm cells were detected in plasma line from centrifuge and 5 occurrences of alarm system continued to detect cells in plasma line from centrifuge and in the terumobct.Com second procedure analyzed there were 7 occurrence of the alarm system continued to detect cells in plasma line from centrifuge and 2 occurrences of alarm cells were detected in plasma line from centrifuge.These alarms are raised by the control system when it detects the ratio of the reflectance between the red and green leds on the rbc detector exceeds a value of 1.5.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hct was too low causing cells to exit through the plasma line, a shift in fluid balance that caused the actual patient hct to increase as the procedure progressed, or hemolysis may have been present possibly due to the patient related disease state.When this alarm is raised, the system categorizes it as a spillover condition and safety disallows exchange since a spillover may lead to lost rbcs.To respond to this alarm, the operator should look through the view port to see the position of the rbc interface.If the interface is too high or there are swirls of platelets in the plasma it is recommended to increase the patient hct by 3 percentage points.If the alarm recurs, increase the hematocrit by 3 percentage points again.The operator may increase the hct this way up to three times for a maximum increase of 9 percentage points.The input patient hct directly controls the pump flow rates which control the position of the interface.In the first procedure, the operator increased the patient hct up to 46% from a starting value of 30%.In the second procedure, the operator started at 22% patient hct and ranged between 20% and 30% throughout the procedure.A higher rbc detector signal generally signifies a darker color at the plasma line which in turn may indicate a greater cell presence.However, this detector signal cannot indicate what kind of cells are present in the plasma line and cannot confirm the occurrence of hemolysis.If hemolysis is suspected, it is important to consider if the patient condition may cause it and perform hemolysis testing to confirm.In this procedure, aim images do not show a high cell interface in the channel connector.The first procedure was ended by the operator by selecting the rinseback option from the alarm screen for the alarm system continued to detect cells in plasma line from centrifuge.In the second procedure analyzed, the operator pressed the stop button at roughly 13 minutes into the procedure.Following the press of the stop button, the system raised several alarms indicating a fault of pump 5.The alarms that were raised were pump 5 did not stop when commanded, calculation of pump rpm was not consistent, pump 5 malfunctioned, and pumps were turned during alarm.The final of these only gives the operator the option to reset (restart) the device in order to proceed.The alarm pump 5 did not stop when commanded is raised when the replace pump did not stop after having been commanded to stop by the system.The alarm calculation of pump rpm was not consistent is raised when the safety system detects that there is a discrepancy between the current rpm rate of pump and what the safety system expects it to be.The alarm pump 5 malfunctioned is raised when the control system is unable to command the pump to a specific rpm.Upon the reboot of this device the alarm pump 5 did not stop when commanded was raised once more.Review of the d log confirms there is a discrepancy between the commanded value to the replace pump and the current value detected by the control and safety computers.The customer reported to have turned pump 5 manually, which was the cause for these alarms.The safety system correctly captured this discrepancy and raised the appropriate alarms.Review of the run data file showed the system to be operating as intended with the appropriate alarms raised.The d log analysis does not show a clear root cause for the reported occurrence of red tinged plasma in the tubing set suspected of hemolysis.Review of the aim images during the procedure confirm the presence of a cell interface and do not show any evidence of clumping in either procedure.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 Description

A terumo bct service tech reported a death after receiving a service call.Per follow up with the customer, the operator tried to clamp the entire tubing at the bottom of the cassette.The pump did not turn when she released it.The customer also stated that the patient was overdue for the procedure therapeutic plasma exchange (tpe).They had to wait to be transferred to another hospital.The same issue happened 2x.The operator turned the pump manually.They got rbc detected alarm.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.The customer stated the patient was in intensive care, not really conscious, agitated, vital signs not alarming (but a little elevated).The customer stated that the doctor at the customer site, ceased maneuvers.The treatment was carried out and observed by the dialysis team at the customers location.Patient received packed red blood cells.The collection set is not available for return because it was discarded by the customer.

Event Description

A terumo bct service tech reported a death after receiving a service call.Per follow up with the customer, the operator tried to clamp the entire tubing at the bottom of the cassette.The pump did not turn when she released it.The customer also stated that the patient was overdue for the procedure therapeutic plasma exchange (tpe).They had to wait to be transferred to another hospital.The same issue happened 2x.The operator turned the pump manually.They got rbc detected alarm.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.The customer stated the patient was in intensive care, not really conscious, agitated, vital signs not alarming (but a little elevated).The customer stated that the doctor at the customer site, ceased maneuvers.The treatment was carried out and observed by the dialysis team at the the customers location.Patient received packed red blood cells.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.In total 5 dlog files spanning 2 separate tpe procedures performed on the same patient were reviewed in this analysis.In the first procedure summarized above, there were 2 occurrences of alarm ¿cells were detected in plasma line from centrifuge¿ and 5 occurrences of alarm ¿system continued to detect cells in plasma line from centrifuge¿.And in the terumobct.Com second procedure analyzed there were 7 occurrence of the alarm ¿system continued to detect cells in plasma line from centrifuge¿ and 2 occurrences of alarm ¿cells were detected in plasma line from centrifuge¿.These alarms are raised by the control system when it detects the ratio of the reflectance between the red and green leds on the rbc detector exceeds a value of 1.5.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hct was too low causing cells to exit through the plasma line, a shift in fluid balance that caused the actual patient hct to increase as the procedure progressed, or hemolysis may have been present possibly due to the patient related disease state.When this alarm is raised, the system categorizes it as a ¿spillover condition¿ and safety disallows exchange since a spillover may lead to lost rbc¿s.To respond to this alarm, the operator should look through the view port to see the position of the rbc interface.If the interface is too high or there are swirls of platelets in the plasma it is recommended to increase the patient hct by 3 percentage points.If the alarm recurs, increase the hematocrit by 3 percentage points again.The operator may increase the hct this way up to three times for a maximum increase of 9 percentage points.The input patient hct directly controls the pump flow rates which control the position of the interface.In the first procedure, the operator increased the patient hct up to 46% from a starting value of 30%.In the second procedure, the operator started at 22% patient hct and ranged between 20% and 30% throughout the procedure.A higher rbc detector signal generally signifies a darker color at the plasma line which in turn may indicate a greater cell presence.However, this detector signal cannot indicate what kind of cells are present in the plasma line and cannot confirm the occurrence of hemolysis.If hemolysis is suspected, it is important to consider if the patient condition may cause it and perform hemolysis testing to confirm.In this procedure, aim images do not show a high cell interface in the channel connector.The first procedure was ended by the operator by selecting the rinseback option from the alarm screen for the alarm ¿system continued to detect cells in plasma line from centrifuge¿.In the second procedure analyzed, the operator pressed the stop button at roughly 13 minutes into the procedure.Following the press of the stop button, the system raised several alarms indicating a fault of pump 5.The alarms that were raised were ¿pump 5 did not stop when commanded¿, ¿calculation of pump rpm was not consistent¿, ¿pump 5 malfunctioned¿, and ¿pumps were turned during alarm¿.The final of these only gives the operator the option to reset (restart) the device in order to proceed.The alarm ¿pump 5 did not stop when commanded is raised when the replace pump did not stop after having been commanded to stop by the system.The alarm ¿calculation of pump rpm was not consistent¿ is raised when the safety system detects that there is a discrepancy between the current rpm rate of pump and what the safety system expects it to be.The alarm ¿pump 5 malfunctioned¿ is raised when the control system is unable to command the pump to a specific rpm.Upon the reboot of this device the alarm ¿pump 5 did not stop when commanded¿ was raised once more.Review of the dlog confirms there is a discrepancy between the commanded value to the replace pump and the current value detected by the control and safety computers.The customer reported to have turned pump 5 manually, which was the cause for these alarms.The safety system correctly captured this discrepancy and raised the appropriate alarms.Review of the run data file showed the system to be operating as intended with the appropriate alarms raised.The dlog analysis does not show a clear root cause for the reported occurrence of red tinged plasma in the tubing set suspected of hemolysis.Review of the aim images during the procedure confirm the presence of a cell interface and do not show any evidence of clumping in either procedure.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 both lots and found no other reports for other occurrences on either lot worldwide.A service call was conducted.The service technician demonstrated the proper way to remove air bubbles by pinching the plasma line.During the process of removing air bubbles, pump 5 would stop, which is normal during the air removal process.Once air bubbles on the rbc detector are removed, pump 5 would start turning and resume the procedure.The device is confirmed to be functioning as intended.Based on terumobct internal medical review conclusion, the multiple alarms received indicates that the spectra optia performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused adverse events.Root cause: a root cause assessment was performed for this complaint.Based on the available information and the information provided by the customer, a definitive root cause for the patient death could not be determined.Possible causes include but are not limited to: * the patient's underlying disease state * an undisclosed medical condition a root cause assessment was performed for this complaint.Based on the available information and the information provided by the customer, a definitive root cause for the ¿cells were detected in plasma channel line¿ alarms could not be determined.Possible causes include but are not limited to: * the patient¿s underlying disease state * air bubbles in the plasma line falsely triggering the rbc detector.A root cause assessment was performed for this complaint.Based on the run data file analysis, the alarms that were raised were ¿pump 5 did not stop when commanded¿, ¿calculation of pump rpm was not consistent¿, ¿pump 5 malfunctioned¿, and ¿pumps were turned during alarm¿.The final of these only gives the operator the option to reset (restart) the device in order to proceed.The alarm ¿pump 5 did not stop when commanded is raised when the replace pump did not stop after having been commanded to stop by the system.The alarm ¿calculation of pump rpm was not consistent¿ is raised when the safety system detects that there is a discrepancy between the current rpm rate of pump and what the safety system expects it to be.The alarm ¿pump 5 malfunctioned¿ is raised when the control system is unable to command the pump to a specific rpm.Upon the reboot of this device the alarm ¿pump 5 did not stop when commanded¿ was raised once more.Review of the dlog confirms there is a discrepancy between the commanded value to the replace pump and the current value detected by the control and safety computers.The customer reported to have turned pump 5 manually, which was the cause for these alarms.The safety system correctly captured this discrepancy and raised the appropriate alarms.

• 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: 18367604
• MDR Text Key: 331048818
• Report Number: 1722028-2023-00417
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 4122201
• Device Lot Number: 2304143141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2023
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 82 KG