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

Model Number 12220

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used optia exchange set was returned for investigation.It is noted that the set was not packed on ice for the return.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.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were signs of clumping and clotting in the set.All witness and wear marks indicate individual loop and channel components were properly loaded.The run data file (rdf) was analyzed for this event.Signals in the run data files do not indicate a conclusive cause for the reported hemolysis.The file shows that the device operated as intended and is safe for continued use.The pumps operated within the normal limits and there were no abnormalities in the pressure or level sensor readings.The aim images were clear, and the lighting was within specification.Review of the dlog and associated images for this procedure confirmed the presence of clumping in the connector during the procedure.Clumping first appeared 56 minutes into the procedure.The inlet:ac ratio was set to 13:1 initially but was decreased to 8:1 approximately 66 minutes into the procedure.The operator then increased the inlet:ac ration back to 13:1 at 89 minutes, when clumping was still present in the connector.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed or suspected, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8:1.Once a clump has been resolved, a ratio that maintains adequate separation should be used which may be lower than initially set to ensure adequate anticoagulation.The inlet:ac ratio was set at a value of 12:1 and not properly adjusted during these runs.If clumping persists or worsens, especially after a lower inlet:ac ratio has been entered, it is recommended to verify that ac fluid is flowing into the drip chamber to ensure proper anticoagulation of the set.For more information on managing ac, refer to the section of called "managing anticoagulation of the extracorporeal circuit" in the "troubleshooting" section in the spectra optia apheresis system operator's manual.Review of the dlog and aim images also show several occurrences of the aim system detected rbc interface near top of channel' alarm indicating that the rbc interface was higher than expected in the channel.The images and signals show that the plasma was dark from the beginning of the procedure.The cause for this behavior is related to the patient's individual blood physiology.Signals from the rbc detector also confirmed darker plasma going by the detector, seen by a significant decrease in the red/green reflectance signal, over the entire run.Dark plasma is often a result of either the patient's disease state (possibly hemolysis or excess bilirubin in the plasma) or medications the patient is currently on.The patient's plasma became even more dark approximately one hour into the procedure, shortly after the second replacement unit was attached and this triggered the first of these alarms.The aim system is not used to control the interface position in an rbcx procedure; rather, it is only used to detect high interface positions as part of spillover detection.Therefore, if this situation occurs in the future and the physician has determined it safe to proceed with the rbcx procedure based on the patient's condition, the operator should consider switching the device to semi-automatic mode or as was done in this procedure disabling the aim system to mitigate the alarms.Note that with both semi-automatic mode and disabling the aim system, the top channel intensity is no longer monitored, and these alarms will not be generated however in semi-automatic mode there is flexibility to go back to automatic mode if desired.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an aim detected rbc near top of channel alarm during a red blood cell exchange (rbcx) procedure on a sickle cell anemia patient.The patients original hct was 26 and the operator increased the hct from 29 to 32.In the picture provided by the customer the plasma is orangish.Tbct customer support had the customer check the fluids hanging and per the customer everything was correct.The discoloration in the plasma didn't occur until after then 2nd bag and at the beginning of the 3rd bag.Customer support told the customer to start a saline drip to the patient and call the physician.Per the customer the patient is stable and was discharged home.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A used optia exchange set was returned for investigation.It is noted that the set was not packed on ice for the return.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.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were signs of clumping and clotting in the set.All witness and wear marks indicate individual loop and channel components were properly loaded.The run data file (rdf) was analyzed for this event.Signals in the run data files do not indicate a conclusive cause for the reported hemolysis.The file shows that the device operated as intended and is safe for continued use.The pumps operated within the normal limits and there were no abnormalities in the pressure or level sensor readings.The aim images were clear, and the lighting was within specification.Review of the blog and associated images for this procedure confirmed the presence of clumping in the connector during the procedure.Clumping first appeared 56 minutes into the procedure.The inlet:ac ratio was set to 13:1 initially but was decreased to 8:1 approximately 66 minutes into the procedure.The operator then increased the inlet:ac ration back to 13:1 at 89 minutes, when clumping was still present in the connector.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed or suspected, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8:1.Once a clump has been resolved, a ratio that maintains adequate separation should be used which may be lower than initially set to ensure adequate anticoagulation.The inlet:ac ratio was set at a value of 12:1 and not properly adjusted during these runs.If clumping persists or worsens, especially after a lower inlet:ac ratio has been entered, it is recommended to verify that ac fluid is flowing into the drip chamber to ensure proper anticoagulation of the set.For more information on managing ac, refer to the section of called "managing anticoagulation of the extracorporeal circuit" in the "troubleshooting" section in the spectra optia apheresis system operator's manual.Review of the blog and aim images also show several occurrences of the aim system detected rbc interface near top of channel' alarm indicating that the rbc interface was higher than expected in the channel.The images and signals show that the plasma was dark from the beginning of the procedure.The cause for this behavior is related to the patient's individual blood physiology.Signals from the rbc detector also confirmed darker plasma going by the detector, seen by a significant decrease in the red/green reflectance signal, over the entire run.Dark plasma is often a result of either the patient's disease state (possibly hemolysis or excess bilirubin in the plasma) or medications the patient is currently on.The patient's plasma became even more dark approximately one hour into the procedure, shortly after the second replacement unit was attached and this triggered the first of these alarms.The aim system is not used to control the interface position in an rbcx procedure; rather, it is only used to detect high interface positions as part of spillover detection.Therefore, if this situation occurs in the future and the physician has determined it safe to proceed with the rbcx procedure based on the patient's condition, the operator should consider switching the device to semi-automatic mode or as was done in this procedure disabling the aim system to mitigate the alarms.Note that with both semi-automatic mode and disabling the aim system, the top channel intensity is no longer monitored, and these alarms will not be generated however in semi-automatic mode there is flexibility to go back to automatic mode if desired.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an aim detected rbc near top of channel alarm during a red blood cell exchange (rbcx) procedure on a sickle cell anemia patient.The patients original hct was 26 and the operator increased the hct from 29 to 32.In the picture provided by the customer the plasma is orangish.Tbct customer support had the customer check the fluids hanging and per the customer everything was correct.The discoloration in the plasma didn't occur until after then 2nd bag and at the beginning of the 3rd bag.Customer support told the customer to start a saline drip to the patient and call the physician.Per the customer the patient is stable and was discharged home.

Event Description

The customer reported an aim detected rbc near top of channel alarm during a red blood cell exchange (rbcx) procedure on a sickle cell anemia patient.The patients original hct was 26 and the operator increased the hct from 29 to 32.In the picture provided by the customer the plasma is orangish.Tbct customer support had the customer check the fluids hanging and per the customer everything was correct.The discoloration in the plasma didn't occur until after then 2nd bag and at the beginning of the 3rd bag.Customer support told the customer to start a saline drip to the patient and call the physician.Per the customer the patient is stable and was discharged home.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A used optia exchange set was returned for investigation.It is noted that the set was not packed on ice for the return.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.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were signs of clumping and clotting in the set.All witness and wear marks indicate individual loop and channel components were properly loaded.The run data file (rdf) was analyzed for this event.Signals in the run data files do not indicate a conclusive cause for the reported hemolysis.The file shows that the device operated as intended and is safe for continued use.The pumps operated within the normal limits and there were no abnormalities in the pressure or level sensor readings.The aim images were clear, and the lighting was within specification.Review of the dlog and associated images for this procedure confirmed the presence of clumping in the connector during the procedure.Clumping first appeared 56 minutes into the procedure.The inlet:ac ratio was set to 13:1 initially but was decreased to 8:1 approximately 66 minutes into the procedure.The operator then increased the inlet:ac ration back to 13:1 at 89 minutes, when clumping was still present in the connector.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed or suspected, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8:1.Once a clump has been resolved, a ratio that maintains adequate separation should be used which may be lower than initially set to ensure adequate anticoagulation.The inlet:ac ratio was set at a value of 12:1 and not properly adjusted during these runs.If clumping persists or worsens, especially after a lower inlet:ac ratio has been entered, it is recommended to verify that ac fluid is flowing into the drip chamber to ensure proper anticoagulation of the set.For more information on managing ac, refer to the section of called "managing anticoagulation of the extracorporeal circuit" in the "troubleshooting" section in the spectra optia apheresis system operator's manual.Review of the dlog and aim images also show several occurrences of the aim system detected rbc interface near top of channel' alarm indicating that the rbc interface was higher than expected in the channel.The images and signals show that the plasma was dark from the beginning of the procedure.The cause for this behavior is related to the patient's individual blood physiology.Signals from the rbc detector also confirmed darker plasma going by the detector, seen by a significant decrease in the red/green reflectance signal, over the entire run.Dark plasma is often a result of either the patient's disease state (possibly hemolysis or excess bilirubin in the plasma) or medications the patient is currently on.The patient's plasma became even more dark approximately one hour into the procedure, shortly after the second replacement unit was attached and this triggered the first of these alarms.The aim system is not used to control the interface position in an rbcx procedure; rather, it is only used to detect high interface positions as part of spillover detection.Therefore, if this situation occurs in the future and the physician has determined it safe to proceed with the rbcx procedure based on the patient's condition, the operator should consider switching the device to semi-automatic mode or as was done in this procedure disabling the aim system to mitigate the alarms.Note that with both semi-automatic mode and disabling the aim system, the top channel intensity is no longer monitored, and these alarms will not be generated however in semi-automatic mode there is flexibility to go back to automatic mode if desired.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.Root cause: a root cause assessment was performed for this complaint.Based on the rdf analysis, the pictures and the plasma free hemoglobin test results, the root cause was determined to be clotting in the channel that resulted in shear induced hemolysis.A root cause assessment was performed for this complaint.Based on the available information a definitive root cause for issue with the clotting could not be determined but it is likely due to one or a combination of the possible causes listed below: * the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.* activation of platelets as a result of the patient's physiology.* pausing the procedure but not the calcium infusion could cause clumping in the return line and potentially the circuit.* giving a bolus of calcium rather than a continuous infusion could also increase the likelihood of clumping in the circuit.* excessive calcium infusion in combination with a higher inlet:ac ratio could lead to clotting in the circuit.

• 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 ; 3032314970
• MDR Report Key: 12129127
• MDR Text Key: 262642837
• Report Number: 1722028-2021-00230
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2105203130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 38 KG