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

Model Number 12220

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

Patient Problem Hemolysis (1886)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

The customer reported hemolysis in the connector and waste bag during the beginning a therapeutic plasma exchange (tpe) procedure on a patient with encephalitis.They received alarms that the aim system couldn't raise to correct position and the plasma was "diluted red".The physician at the customer site was bedside and indicated there was no apparent reason the diagnosis that would indicate hemolysis.The hanging fluids were checked and the pharmacy confirmed they were mixed correctly and the procedure was continued.The patient is reported in stable condition and no medical intervention was required.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

Investigation: per the customer, fluids hanging were acda, 0.9% normal saline and 5% albumin.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported hemolysis in the connector and waste bag during the beginning a therapeutic plasma exchange (tpe) procedure on a patient with encephalitis.They received alarms that the aim system couldn't raise to correct position and the plasma was "diluted red".The physician at the customer site was bedside and indicated there was no apparent reason the diagnosis that would indicate hemolysis.The hanging fluids were checked and the pharmacy confirmed they were mixed correctly and the procedure was continued.The patient is reported in stable condition and no medical intervention was required.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.3, h.6 and h.10.Investigation: per the customer, fluids hanging were acda, 0.9% normal saline and 5% albumin.A used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Clumping and clotting were seen throughout the set as well.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the lower hex were inspected for evidence of loading.The marks indicate the lower hex was loaded in a non-optimal position which may have contributed to the reported failure.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information investigation: per the customer, fluids hanging were acda, 0.9% normal saline and 5% albumin.A used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Clumping and clotting were seen throughout the set as well.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the lower hex were inspected for evidence of loading.The marks indicate the lower hex was loaded in a non-optimal position which may have contributed to the reported failure.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.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

The customer reported hemolysis in the connector and waste bag during the beginning a therapeutic plasma exchange (tpe) procedure on a patient with encephalitis.They received alarms that the aim system couldn't raise to correct position and the plasma was "diluted red".The physician at the customer site was bedside and indicated there was no apparent reason the diagnosis that would indicate hemolysis.The hanging fluids were checked and the pharmacy confirmed they were mixed correctly and the procedure was continued.The patient is reported in stable condition and no medical intervention was required.

Event Description

The customer reported hemolysis in the connector and waste bag during the beginning a therapeutic plasma exchange (tpe) procedure on a patient with encephalitis.They received alarms that the aim system couldn't raise to correct position and the plasma was "diluted red".The physician at the customer site was bedside and indicated there was no apparent reason the diagnosis that would indicate hemolysis.The hanging fluids were checked and the pharmacy confirmed they were mixed correctly and the procedure was continued.The patient is reported in stable condition and no medical intervention was required.

Manufacturer Narrative

This report is being filed to provide investigation: per the customer, fluids hanging were acda, 0.9% normal saline and 5% albumin.A used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Clumping and clotting were seen throughout the set as well.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the lower hex were inspected for evidence of loading.The marks indicate the lower hex was loaded in a non-optimal position which may have contributed to the reported failure.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.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.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 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 not significant enough to raise an alarm.As the procedure continued, the rbc signals continued to decrease suggesting the color of the plasma was clearing up as the procedure progressed.Depending on the specific patient diagnosis this may be expected behavior as more plasma is replaced.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 establish target interface¿.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.Rdf analysis shows this alarm only occurred once during this procedure.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: per the customer, fluids hanging were acda, 0.9% normal saline and 5% albumin.A device functional check was requested and carried out by a terumo bct service technician, no issues were identified.A used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Clumping and clotting were seen throughout the set as well.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the lower hex were inspected for evidence of loading.The marks indicate the lower hex was loaded in a non-optimal position which may have contributed to the reported failure.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.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.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 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 not significant enough to raise an alarm.As the procedure continued, the rbc signals continued to decrease suggesting the color of the plasma was clearing up as the procedure progressed.Depending on the specific patient diagnosis this may be expected behavior as more plasma is replaced.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 establish target interface¿.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.Rdf analysis shows this alarm only occurred once during this procedure.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported hemolysis in the connector and waste bag during the beginning a therapeutic plasma exchange (tpe) procedure on a patient with encephalitis.They received alarms that the aim system couldn't raise to correct position and the plasma was "diluted red".The physician at the customer site was bedside and indicated there was no apparent reason the diagnosis that would indicate hemolysis.The hanging fluids were checked and the pharmacy confirmed they were mixed correctly and the procedure was continued.The patient is reported in stable condition and no medical intervention was required.

Event Description

The customer reported hemolysis in the connector and waste bag during the beginning a therapeutic plasma exchange (tpe) procedure on a patient with encephalitis.They received alarms that the aim system couldn't raise to correct position and the plasma was "diluted red".The physician at the customer site was bedside and indicated there was no apparent reason the diagnosis that would indicate hemolysis.The hanging fluids were checked and the pharmacy confirmed they were mixed correctly and the procedure was continued.The patient is reported in stable condition and no medical intervention was required.Patient id is unavailable as the customer is not willing to provide this information.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: per the customer, fluids hanging were acda, 0.9% normal saline and 5% albumin.A device functional check was requested and carried out by a terumo bct service technician, no issues were identified.A used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Clumping and clotting were seen throughout the set as well.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.Witness and wear marks on the lower hex were inspected for evidence of loading.The marks indicate the lower hex was loaded in a non-optimal position which may have contributed to the reported failure.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.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.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 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 not significant enough to raise an alarm.As the procedure continued, the rbc signals continued to decrease suggesting the color of the plasma was clearing up as the procedure progressed.Depending on the specific patient diagnosis this may be expected behavior as more plasma is replaced.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 establish target interface¿¿¿.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.Rdf analysis shows this alarm only occurred once during this procedure.Root cause: a root cause assessment was performed for this complaint.Review of the dlog and associated aim images does not show a clear root cause for the reported occurrence of red tinged plasma in the remove 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 not significant enough to raise an alarm.As the procedure continued, the rbc signals continued to decrease suggesting the color of the plasma was clearing up as the procedure progressed.Depending on the specific patient diagnosis this may be expected behavior as more plasma is replaced.Analysis of the dlog is not able to confirm the occurrence of hemolysis during this procedure.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: * hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.* hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.* patient's medication and/or medical treatment.

• 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: 17127843
• MDR Text Key: 317255337
• Report Number: 1722028-2023-00211
• 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,Followup,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12220
• Device Catalogue Number: 4122201
• Device Lot Number: 2301276141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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: 15 YR
• Patient Sex: Female
• Patient Weight: 68 KG