| Model Number 12220 |
| Device Problems
Device Alarm System (1012); Excess Flow or Over-Infusion (1311); Increase in Pressure (1491)
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| Patient Problem
Hypervolemia (2664)
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| Event Date 11/15/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation: based on calculations of information provided by the customer, the patient's final fluid balance was 341%.A used optia set containing blood was returned to terumo bct for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the disposable set.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that 182 min into a red blood cell exchange (rbcx) procedure on a pediatric patient with sickle cell, she noticed that the removed bag did not contain the volume that was displayed on the screen run values.The patient was very upset and the procedure had been paused to deal with several patient issues.The operator indicated that they had experienced alarms since the beginning of the procedure such as "return pressure high" and "fluid balance may be higher than reported".The operator discontinued the procedure with approximately 17 min left, contacted tbct, the medical director and the manager.The patient was disconnected and moved to the intensive care unit (icu).No risneback was performed.The pre-hematocrit was 28% and the target end hematocrit was 30%, they achieved and end hematocrit of 57% and after the third phlebotomy the hematocrit was 38%.They removed 1150ml, processed 2444 ml and replaced 1084 ml.Per the physician at the customer site, the removal of extra fluid from the patient was required via manual drawing of the blood.After removing 500ml of red cells (260ml after the procedure and 240ml the following day) the patient was stable and moved out of the icu to the normal floor.Per the customer, the day before the procedure on (b)(6) 2021, the patient was flown from savannah to atl for an acute stroke.She had a right side stroke with l side weakness.They put in a double lumen right femoral line for the access.She also has a right side power port that had already been accessed for fluid infusion.Patient id is not available per the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10 and corrected information in b.3.Investigation: based on calculations of information provided by the customer, the patient's final fluid balance was 341%.A used optia set containing blood was returned to terumo bct for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the disposable set.The customer provided five pictures to aid in the investigation.The following observations were made based on the pictures: picture 1: this picture shows a remove bag hung on the iv pole with a very small amount of blood contents remaining in the bag.Picture 2: this picture shows an exchange set correctly loaded into the filler.Picture 3: this picture shows the channel after it was unloaded from the filler.The channel appeared to be full of blood.Picture 4: this picture shows that the plasma line exiting the channel and the plasma line connected to the return reservoir is full of blood confirming the spillover.There is a large clot in the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.The inlet line trap is clotted off and the tubing distal to the filter is completely void of blood.Picture 5: this picture confirmed the same findings as in picture 4.A used optia set containing blood was also returned for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the inlet pump header, inlet line trap, cps and the return reservoir.Blood was also noted in the plasma line confirming the spillover.The patient's diagnosis is sickle cell anemia.She was flown from savannah to atlanta on sunday for an acute stroke.She had a right-side stroke with left side weakness prior to the rbcx procedure.They put in a double lumen right femoral line for the access.She also has a right-side power port that had already been accessed for fluid infusion.The procedure was started at 0806 and there were multiple access alarms as the child kept going into a fetal position.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.According to the run data file analysis, the inlet:ac ratio was 13, and the inlet flow rate was 13.5ml/min.There were numerous 'inlet pressure was too low' alarms and pauses during the first 66 minutes of the procedure.Notes from the nurse confirmed issues with the patient's access, which was likely the cause for these alarms and pauses.Constant pump pauses increased the likelihood of clotting in the circuit.Picture 4 provided by the customer confirmed the presence of a large clot at the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.Additionally, the inlet line trap is clotted off and the tubing distal to the inlet line trap is completely void of blood, which likely led to restriction of blood flow from the patient.The aim system monitors the intensity of the light near the top and bottom of the connector to detect any rbc spillover.When the aim system is disabled, it does not monitor or control the interface position.The rbc detector is used to monitor rbcs in the plasma line during an exchange procedure.As the procedure progressed, the plasma pump continued to run as designed, sending plasma from the channel into the return reservoir.The system detected a rising interface and generated ¿aim system detected rbc interface near top of channel¿ alarms followed by ¿cells were detected in plasma line from centrifuge¿ alarms accordingly at 09:19.The rising interface is consistent with the lack of incoming blood to fill the channel.The aim system was subsequently disabled by the operator at 09:22 and the rbc detector was disabled at 09:29.As the plasma pump continued to pump with the inlet flow restricted/occluded, contents of the remove bag were able to drain by gravity back into the channel through the passive rbc line, effectively replacing the inlet flow, and be returned to the patient via the plasma pump along with the replacement fluid.This scenario was able to be replicated in a lab setting using two units of prepared bovine blood to match the patient's whole blood (hct 28.8%) and the replacement rbc units (hct 52.8%).A simulation procedure was then performed in the lakewood facility using the run parameters configured for this procedure.The inlet flow was restricted from entering the channel by manually occluding the inlet side tubing of the inlet pump.The system generated 'inlet pressure sensor malfunctioned' alarms in response to the interruption of the inlet flow, followed by 'aim system detected rbc interface near top of channel' alarms note that the inlet pressure senor malfunctioned alarm was not generated during the actual procedure.The aim system was subsequently disabled from the alarm screen.The interface continued to rise in the channel after the aim system was disabled.As the channel contents began to spillover into the plasma line, the rbc detector performed as intended by generating 'cells were detected in plasma line from centrifuge' alarms.In response to these alarms, the rbc detector was disabled and the procedure was continued.The contents in the remove bag were visually observed drain back into the channel during this time.There were 'patient's fluid balance may be 5% lower than reported' followed by 'patient fluid balance may be 10% lower than reported' alarms.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that 182 min into a red blood cell exchange (rbcx) procedure on a pediatric patient with sickle cell, she noticed that the remove bag did not contain the volume that was displayed on the screen run values.The patient was very upset and the procedure had been paused to deal with several patient issues.The operator indicated that they had experienced alarms since the beginning of the procedure such as "return pressure high" and "fluid balance may be higher than reported".The operator discontinued the procedure with approximately 17 min left, contacted tbct, the medical director and the manager.The patient was disconnected and moved to the intensive care unit (icu).No rinseback was performed.The pre-hematocrit was 28% and the target end hematocrit was 30%, they achieved and end hematocrit of 57% and after the third phlebotomy the hematocrit was 38%.They removed 1150ml, processed 2444 ml and replaced 1084 ml.Per the physician at the customer site, the removal of extra fluid from the patient was required via manual drawing of the blood.After removing 500ml of red cells (260ml after the procedure and 240ml the following day) the patient was stable and moved out of the icu to the normal floor.Per the customer, the day before the procedure on sunday, (b)(6) 2021, the patient was flown from savannah to atl for an acute stroke.She had a right side stroke with l side weakness.They put in a double lumen right femoral line for the access.She also has a right side power port that had already been accessed for fluid infusion.Patient id is not available per the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.5, b.6, h.6 and h.10.Investigation: based on calculations of information provided by the customer, the patient's final fluid balance was 341%.A used optia set containing blood was returned to terumo bct for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the disposable set.The customer provided five pictures to aid in the investigation.The following observations were made based on the pictures: picture 1: this picture shows a remove bag hung on the iv pole with a very small amount of blood contents remaining in the bag.Picture 2: this picture shows an exchange set correctly loaded into the filler.Picture 3: this picture shows the channel after it was unloaded from the filler.The channel appeared to be full of blood.Picture 4: this picture shows that the plasma line exiting the channel and the plasma line connected to the return reservoir is full of blood confirming the spillover.There is a large clot in the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.The inlet line trap is clotted off and the tubing distal to the filter is completely void of blood.Picture 5: this picture confirmed the same findings as in picture 4.A used optia set containing blood was also returned for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the inlet pump header, inlet line trap, cps and the return reservoir.Blood was also noted in the plasma line confirming the spillover.The patient's diagnosis is sickle cell anemia.She was flown from savannah to atlanta on sunday for an acute stroke.She had a right-side stroke with left side weakness prior to the rbcx procedure.They put in a double lumen right femoral line for the access.She also has a right-side power port that had already been accessed for fluid infusion.The procedure was started at 0806 and there were multiple access alarms as the child kept going into a fetal position.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.According to the run data file analysis, the inlet:ac ratio was 13, and the inlet flow rate was 13.5ml/min.There were numerous 'inlet pressure was too low' alarms and pauses during the first 66 minutes of the procedure.Notes from the nurse confirmed issues with the patient's access, which was likely the cause for these alarms and pauses.Constant pump pauses increased the likelihood of clotting in the circuit.Picture 4 provided by the customer confirmed the presence of a large clot at the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.Additionally, the inlet line trap is clotted off and the tubing distal to the inlet line trap is completely void of blood, which likely led to restriction of blood flow from the patient.The aim system monitors the intensity of the light near the top and bottom of the connector to detect any rbc spillover.When the aim system is disabled, it does not monitor or control the interface position.The rbc detector is used to monitor rbcs in the plasma line during an exchange procedure.As the procedure progressed, the plasma pump continued to run as designed, sending plasma from the channel into the return reservoir.The system detected a rising interface and generated ¿aim system detected rbc interface near top of channel¿ alarms followed by ¿cells were detected in plasma line from centrifuge¿ alarms accordingly at 09:19.The rising interface is consistent with the lack of incoming blood to fill the channel.The aim system was subsequently disabled by the operator at 09:22 and the rbc detector was disabled at 09:29.As the plasma pump continued to pump with the inlet flow restricted/occluded, contents of the remove bag were able to drain by gravity back into the channel through the passive rbc line, effectively replacing the inlet flow, and be returned to the patient via the plasma pump along with the replacement fluid.This scenario was able to be replicated in a lab setting using two units of prepared bovine blood to match the patient's whole blood (hct 28.8%) and the replacement rbc units (hct 52.8%).A simulation procedure was then performed in the (b)(6) facility using the run parameters configured for this procedure.The inlet flow was restricted from entering the channel by manually occluding the inlet side tubing of the inlet pump.The system generated 'inlet pressure sensor malfunctioned' alarms in response to the interruption of the inlet flow, followed by 'aim system detected rbc interface near top of channel' alarms note that the inlet pressure senor malfunctioned alarm was not generated during the actual procedure.The aim system was subsequently disabled from the alarm screen.The interface continued to rise in the channel after the aim system was disabled.As the channel contents began to spillover into the plasma line, the rbc detector performed as intended by generating 'cells were detected in plasma line from centrifuge' alarms.In response to these alarms, the rbc detector was disabled and the procedure was continued.The contents in the remove bag were visually observed drain back into the channel during this time.There were 'patient's fluid balance may be 5% lower than reported' followed by 'patient fluid balance may be 10% lower than reported' alarms.A disposable lot history search indicated there were no other reported occurrences of adverse reactions on this lot worldwide.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that 182 min into a red blood cell exchange (rbcx) procedure on a pediatric patient with sickle cell, she noticed that the remove bag did not contain the volume that was displayed on the screen run values.The patient was very upset and the procedure had been paused to deal with several patient issues.The operator indicated that they had experienced alarms since the beginning of the procedure such as "return pressure high" and "fluid balance may be higher than reported".The operator discontinued the procedure with approximately 17 min left, contacted tbct, the medical director and the manager.The patient was disconnected and moved to the intensive care unit (icu).No rinseback was performed.The pre-hematocrit was 28% and the target end hematocrit was 30%, they achieved and end hematocrit of 57% and after the third phlebotomy the hematocrit was 38%.They removed 1150ml, processed 2444 ml and replaced 1084 ml.Per the physician at the customer site, the removal of extra fluid from the patient was required via manual drawing of the blood.After removing 500ml of red cells (260ml after the procedure and 240ml the following day) the patient was stable and moved out of the icu to the normal floor.Per the customer, the day before the procedure on sunday, (b)(6) 2021, the patient was flown from (b)(6) for an acute stroke.She had a right side stroke with l side weakness.They put in a double lumen right femoral line for the access.She also has a right side power port that had already been accessed for fluid infusion.According to the notes provided by the nurse, the timeline of the event was as follows: 0900: the treatment was paused related to pressure alarms and the lines were reversed and straightened.0925: the machine alarms 'low level reservoir patient fluid balance lower than detected, cells in plasma, troubleshooting done, aims was disabled.1019: there was an issue with vascath (fem) and they were unable to aspirate or flush red lumen.Blue lumen sluggish aspirate but it was determined it was ok to use chest port.1020: the red lumen was capped and the inlet was switched to port 1130: the patient's blood pressure was (bp) 130/114 related to crying/movement between 1136-1150: the pain was reported as intolerable.The patient's mother requested pain med from picu rn treatment paused 1146: toradol iv was given through blue lumen (return) treatment resumed 1150: treatment paused due to patient screaming and grabbing leg.They observed machine/machine settings and noticed the bag had approximately 150-200 cc.Treatment stopped and the md and nurse manager were notified 1155: contacted terumo bct customer support.1205: determined it was ok to disconnect patient and end treatment 1211: the patient was capped off because both blue and red lumen were no longer flushing nor aspirating.Patient id is not available per the customer.
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Event Description
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The customer reported that 182 min into a red blood cell exchange (rbcx) procedure on a pediatric patient with sickle cell, she noticed that the remove bag did not contain the volume that was displayed on the screen run values.The patient was very upset and the procedure had been paused to deal with several patient issues.The operator indicated that they had experienced alarms since the beginning of the procedure such as "return pressure high" and "fluid balance may be higher than reported".The operator discontinued the procedure with approximately 17 min left, contacted tbct, the medical director and the manager.The patient was disconnected and moved to the intensive care unit (icu).No rinseback was performed.The pre-hematocrit was 28% and the target end hematocrit was 30%, they achieved and end hematocrit of 57% and after the third phlebotomy the hematocrit was 38%.They removed 1150ml, processed 2444 ml and replaced 1084 ml.Per the physician at the customer site, the removal of extra fluid from the patient was required via manual drawing of the blood.After removing 500ml of red cells (260ml after the procedure and 240ml the following day) the patient was stable and moved out of the icu to the normal floor.Per the customer, the day before the procedure on sunday, (b)(6) 2021, the patient was flown from (b)(6) for an acute stroke.She had a right side stroke with l side weakness.They put in a double lumen right femoral line for the access.She also has a right side power port that had already been accessed for fluid infusion.According to the notes provided by the nurse, the timeline of the event was as follows: 0900: the treatment was paused related to pressure alarms and the lines were reversed and straightened.0925: the machine alarms 'low level reservoir patient fluid balance lower than detected, cells in plasma, troubleshooting done, aims was disabled.1019: there was an issue with vascath (fem) and they were unable to aspirate or flush red lumen.Blue lumen sluggish aspirate but it was determined it was ok to use chest port.1020: the red lumen was capped and the inlet was switched to port 1130: the patient's blood pressure was (bp) 130/114 related to crying/movement between 1136-1150: the pain was reported as intolerable.The patient's mother requested pain med from picu rn treatment paused 1146: toradol iv was given through blue lumen (return) treatment resumed 1150: treatment paused due to patient screaming and grabbing leg.They observed machine/machine settings and noticed the bag had approximately 150-200 cc.Treatment stopped and the md and nurse manager were notified 1155: contacted terumo bct customer support.1205: determined it was ok to disconnect patient and end treatment 1211: the patient was capped off because both blue and red lumen were no longer flushing nor aspirating.Patient id is not available per the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.5, b.6, h.6 and h.10.Investigation: based on calculations of information provided by the customer, the patient's final fluid balance was 341%.A used optia set containing blood was returned to terumo bct for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the disposable set.The customer provided five pictures to aid in the investigation.The following observations were made based on the pictures: picture 1: this picture shows a remove bag hung on the iv pole with a very small amount of blood contents remaining in the bag.Picture 2: this picture shows an exchange set correctly loaded into the filler.Picture 3: this picture shows the channel after it was unloaded from the filler.The channel appeared to be full of blood.Picture 4: this picture shows that the plasma line exiting the channel and the plasma line connected to the return reservoir is full of blood confirming the spillover.There is a large clot in the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.The inlet line trap is clotted off and the tubing distal to the filter is completely void of blood.Picture 5: this picture confirmed the same findings as in picture 4.A used optia set containing blood was also returned for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the inlet pump header, inlet line trap, cps and the return reservoir.Blood was also noted in the plasma line confirming the spillover.The patient's diagnosis is sickle cell anemia.She was flown from (b)(6) on sunday for an acute stroke.She had a right-side stroke with left side weakness prior to the rbcx procedure.They put in a double lumen right femoral line for the access.She also has a right-side power port that had already been accessed for fluid infusion.The procedure was started at 0806 and there were multiple access alarms as the child kept going into a fetal position.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.According to the run data file analysis, the inlet:ac ratio was 13, and the inlet flow rate was 13.5ml/min.There were numerous 'inlet pressure was too low' alarms and pauses during the first 66 minutes of the procedure.Notes from the nurse confirmed issues with the patient's access, which was likely the cause for these alarms and pauses.Constant pump pauses increased the likelihood of clotting in the circuit.Picture 4 provided by the customer confirmed the presence of a large clot at the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.Additionally, the inlet line trap is clotted off and the tubing distal to the inlet line trap is completely void of blood, which likely led to restriction of blood flow from the patient.The aim system monitors the intensity of the light near the top and bottom of the connector to detect any rbc spillover.When the aim system is disabled, it does not monitor or control the interface position.The rbc detector is used to monitor rbcs in the plasma line during an exchange procedure.As the procedure progressed, the plasma pump continued to run as designed, sending plasma from the channel into the return reservoir.The system detected a rising interface and generated ¿aim system detected rbc interface near top of channel¿ alarms followed by ¿cells were detected in plasma line from centrifuge¿ alarms accordingly at 09:19.The rising interface is consistent with the lack of incoming blood to fill the channel.The aim system was subsequently disabled by the operator at 09:22 and the rbc detector was disabled at 09:29.As the plasma pump continued to pump with the inlet flow restricted/occluded, contents of the remove bag were able to drain by gravity back into the channel through the passive rbc line, effectively replacing the inlet flow, and be returned to the patient via the plasma pump along with the replacement fluid.This scenario was able to be replicated in a lab setting using two units of prepared bovine blood to match the patient's whole blood (hct 28.8%) and the replacement rbc units (hct 52.8%).A simulation procedure was then performed in the (b)(6) facility using the run parameters configured for this procedure.The inlet flow was restricted from entering the channel by manually occluding the inlet side tubing of the inlet pump.The system generated 'inlet pressure sensor malfunctioned' alarms in response to the interruption of the inlet flow, followed by 'aim system detected rbc interface near top of channel' alarms note that the inlet pressure senor malfunctioned alarm was not generated during the actual procedure.The aim system was subsequently disabled from the alarm screen.The interface continued to rise in the channel after the aim system was disabled.As the channel contents began to spillover into the plasma line, the rbc detector performed as intended by generating 'cells were detected in plasma line from centrifuge' alarms.In response to these alarms, the rbc detector was disabled and the procedure was continued.The contents in the remove bag were visually observed drain back into the channel during this time.There were 'patient's fluid balance may be 5% lower than reported' followed by 'patient fluid balance may be 10% lower than reported' alarms.A disposable lot history search indicated there were no other reported occurrences of adverse reactions on this lot worldwide.Correction: terumo bct senior specialist apheresis services has offered customer training for this issue.Investigation is in process.A follow-up report will be provided.
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Manufacturer Narrative
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Investigation: based on calculations of information provided by the customer, the patient's final fluid balance was 341%.A used optia set containing blood was returned to terumo bct for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the disposable set.The customer provided five pictures to aid in the investigation.The following observations were made based on the pictures: picture 1: this picture shows a remove bag hung on the iv pole with a very small amount of blood contents remaining in the bag.Picture 2: this picture shows an exchange set correctly loaded into the filler.Picture 3: this picture shows the channel after it was unloaded from the filler.The channel appeared to be full of blood.Picture 4: this picture shows that the plasma line exiting the channel and the plasma line connected to the return reservoir is full of blood confirming the spillover.There is a large clot in the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.The inlet line trap is clotted off and the tubing distal to the filter is completely void of blood.Picture 5: this picture confirmed the same findings as in picture 4.A used optia set containing blood was also returned for investigation.It was noted that the blood had circulated throughout the set.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.All witness and wear marks indicate individual loop and channel components were properly loaded.Some clumping and clotting were noted in the inlet pump header, inlet line trap, cps and the return reservoir.Blood was also noted in the plasma line confirming the spillover.The patient's diagnosis is sickle cell anemia.She was flown from savannah to atlanta on sunday for an acute stroke.She had a right-side stroke with left side weakness prior to the rbcx procedure.They put in a double lumen right femoral line for the access.She also has a right-side power port that had already been accessed for fluid infusion.The procedure was started at 0806 and there were multiple access alarms as the child kept going into a fetal position.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.According to the run data file analysis, the inlet:ac ratio was 13, and the inlet flow rate was 13.5ml/min.There were numerous 'inlet pressure was too low' alarms and pauses during the first 66 minutes of the procedure.Notes from the nurse confirmed issues with the patient's access, which was likely the cause for these alarms and pauses.Constant pump pauses increased the likelihood of clotting in the circuit.Picture 4 provided by the customer confirmed the presence of a large clot at the centrifuge pressure sensor (cps) and a large air pocket distal to the cps.Additionally, the inlet line trap is clotted off and the tubing distal to the inlet line trap is completely void of blood, which likely led to restriction of blood flow from the patient.The aim system monitors the intensity of the light near the top and bottom of the connector to detect any rbc spillover.When the aim system is disabled, it does not monitor or control the interface position.The rbc detector is used to monitor rbcs in the plasma line during an exchange procedure.As the procedure progressed, the plasma pump continued to run as designed, sending plasma from the channel into the return reservoir.The system detected a rising interface and generated ¿aim system detected rbc interface near top of channel¿ alarms followed by ¿cells were detected in plasma line from centrifuge¿ alarms accordingly at 09:19.The rising interface is consistent with the lack of incoming blood to fill the channel.The aim system was subsequently disabled by the operator at 09:22 and the rbc detector was disabled at 09:29.As the plasma pump continued to pump with the inlet flow restricted/occluded, contents of the remove bag were able to drain by gravity back into the channel through the passive rbc line, effectively replacing the inlet flow, and be returned to the patient via the plasma pump along with the replacement fluid.This scenario was able to be replicated in a lab setting using two units of prepared bovine blood to match the patient's whole blood (hct 28.8%) and the replacement rbc units (hct 52.8%).A simulation procedure was then performed in the lakewood facility using the run parameters configured for this procedure.The inlet flow was restricted from entering the channel by manually occluding the inlet side tubing of the inlet pump.The system generated 'inlet pressure sensor malfunctioned' alarms in response to the interruption of the inlet flow, followed by 'aim system detected rbc interface near top of channel' alarms note that the inlet pressure senor malfunctioned alarm was not generated during the actual procedure.The aim system was subsequently disabled from the alarm screen.The interface continued to rise in the channel after the aim system was disabled.As the channel contents began to spillover into the plasma line, the rbc detector performed as intended by generating 'cells were detected in plasma line from centrifuge' alarms.In response to these alarms, the rbc detector was disabled and the procedure was continued.The contents in the remove bag were visually observed drain back into the channel during this time.There were 'patient's fluid balance may be 5% lower than reported' followed by 'patient fluid balance may be 10% lower than reported' alarms.A disposable lot history search indicated there were no other reported occurrences of adverse reactions on this lot worldwide.Correction: terumo bct senior specialist apheresis services has offered customer training for this issue.Root cause: a root cause assessment was performed for the rbc overload.Based on the information provided by the customer and the simulation run conducted at terumo, the clots in the cassette had prevented the patient's blood from entering the channel.As the plasma pump continued to pump with the inlet flow restricted/occluded, the plasma pump began to pull rbc waste contents from the waste bag through the passive rbc channel line since the rbc valve remained open during the exchange.This reverse flow essentially replaced the incoming blood, causing the interface to rise and spillover into the plasma line.As a result, the rbcs were exiting the channel via the plasma line, into the return reservoir and then back to the patient, with both aim system and rbc detector disabled.In this case, the inlet:ac ratio was set at 13:1, and there were no attempts made to reduce the ac ratio in response to clotting in the set.The issues with the patient's access contributed to numerous inlet access alarms causing pump pauses.As a result, the nurse had to pause the procedure several times in order to address the access issues.Constant pump pauses also increased the likelihood of clotting in the circuit especially running at a very low inlet flow rate.
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Event Description
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The customer reported that 182 min into a red blood cell exchange (rbcx) procedure on a pediatric patient with sickle cell, she noticed that the remove bag did not contain the volume that was displayed on the screen run values.The patient was very upset and the procedure had been paused to deal with several patient issues.The operator indicated that they had experienced alarms since the beginning of the procedure such as "return pressure high" and "fluid balance may be higher than reported".The operator discontinued the procedure with approximately 17 min left, contacted tbct, the medical director and the manager.The patient was disconnected and moved to the intensive care unit (icu).No rinseback was performed.The pre-hematocrit was 28% and the target end hematocrit was 30%, they achieved and end hematocrit of 57% and after the third phlebotomy the hematocrit was 38%.They removed 1150ml, processed 2444 ml and replaced 1084 ml.Per the physician at the customer site, the removal of extra fluid from the patient was required via manual drawing of the blood.After removing 500ml of red cells (260ml after the procedure and 240ml the following day) the patient was stable and moved out of the icu to the normal floor.Per the customer, the day before the procedure on (b)(6) 2021, the patient was flown from savannah to atl for an acute stroke.She had a right side stroke with l side weakness.They put in a double lumen right femoral line for the access.She also has a right side power port that had already been accessed for fluid infusion.According to the notes provided by the nurse, the timeline of the event was as follows: 0900: the treatment was paused related to pressure alarms and the lines were reversed and straightened.0925: the machine alarms 'low level reservoir patient fluid balance lower than detected, cells in plasma, troubleshooting done, aims was disabled.1019: there was an issue with vascath (fem) and they were unable to aspirate or flush red lumen.Blue lumen sluggish aspirate but it was determined it was ok to use chest port.1020: the red lumen was capped and the inlet was switched to port 1130: the patient's blood pressure was (bp) 130/114 related to crying/movement between 1136-1150: the pain was reported as intolerable.The patient's mother requested pain med from picu rn treatment paused 1146: toradol iv was given through blue lumen (return) treatment resumed 1150: treatment paused due to patient screaming and grabbing leg.They observed machine/machine settings and noticed the bag had approximately 150-200 cc.Treatment stopped and the md and nurse manager were notified 1155: contacted terumo bct customer support.1205: determined it was ok to disconnect patient and end treatment 1211: the patient was capped off because both blue and red lumen were no longer flushing nor aspirating.Patient id is not available per the customer.
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