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

TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

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Catalog Number 4122201

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

Patient Problems Dyspnea (1816); Dizziness (2194); Numbness (2415)

Event Date 01/25/2023

Event Type Injury

Event Description

The customer called to report a sickle cell patient who had symptoms of a stroke approximately 30-40 min post red blood cell exchange procedure while the physician was removing the internal jugular (ij) catheter.The patient felt dizzy with shortness of breath, and was unable to move his legs.He was given 500 ml normal saline and had a ct scan which was negative.He was unable to move one of his legs so he was admitted to the hospital.The patient received 50 mg of oral benadryl and 650 mg of tylenol prior to the procedure, and another 3 gm of calcium gluconate in 200 ml of normal saline during the procedure.The patient had a history of stroke.Per the customer, the patient¿s post hematocrit (hct) was higher a day after the procedure.The exchange set is not available for return for evaluation.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf confirms that the operator entered the patient hct of 30% at the start of the procedure and did not change this value throughout the procedure.The customer reported that an actual patient hct reading of 38% came back during the run, which is higher than the original input value.It is essential to enter accurate data when performing an rbcx procedure.Small errors in the data entered can result in large deviations in the expected outcome.In rbcx the patient hematocrit is used by the system to estimate the fraction of cells remaining (fcr), final patient hematocrit, replacement volume used, and it influences the flow rate of the plasma and replace pumps.Since the entered hematocrit was lower than actual, the system based its calculations on a smaller rbc volume entering the system than actual, providing inaccurate estimates of final hct and fcr.It is recommended to have the correct patient data values from the start of the procedure.If it is necessary to update blood counts mid procedure, the operator can update the entered patient hct by pausing the procedure and touching the ¿run¿ menu button and ¿exchange status¿ tab.Here the operator can modify the patient hematocrit parameter to the updated value before resuming the procedure.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the adverse reaction experienced by the customer.Investigation is in process.A follow up report will be provided.

Event Description

The customer called to report a sickle cell patient who had symptoms of a stroke approximately 30-40 min post red blood cell exchange procedure while the physician was removing the internal jugular (ij) catheter.The patient felt dizzy with shortness of breath, and was unable to move his legs.He was given 500 ml normal saline and had a ct scan which was negative.He was unable to move one of his legs so he was admitted to the hospital.The patient received 50 mg of oral benadryl and 650 mg of tylenol prior to the procedure, and another 3 gm of calcium gluconate in 200 ml of normal saline during the procedure.The patient had a history of stroke.It was reported that the patient recovered from the new symptoms he experienced when he had the incident.Per the customer, the patient¿s post hematocrit (hct) was higher a day after the procedure.The exchange set is not available for return for evaluation.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the dlog confirms that the operator entered the patient hct of 30% at the start of the procedure and did not change this value throughout the procedure.The customer reported that an actual patient hct reading of 28.5% came back during the run, which is slightly lower than the input value.It is essential to enter accurate data when performing an rbcx procedure.Small errors in the data entered can result in large deviations in the expected outcome.In rbcx the patient hematocrit is used by the system to estimate the fraction of cells remaining (fcr), final patient hematocrit, replacement volume used, and it influences the flow rate of the plasma and replace pumps.Since the entered hematocrit was higher than actual, the system based its calculations on a higher rbc volume entering the system than actual, possibly providing inaccurate estimates of final hct and fcr.It is recommended to have the correct patient data values from the start of the procedure.If it is necessary to update blood counts mid procedure, the operator can update the entered patient hct by pausing the procedure and touching the ¿run¿ menu button and ¿exchange status¿ tab.Here the operator can modify the patient hematocrit parameter to the updated value before resuming the procedure.The customer reported that a patient post (hct) taken at 18:42 was 38.7%.Dlog analysis did not return a clear root cause for the higher post hct than the machine expected.An incorrect estimate of the final patient hct can also occur if an incorrect replacement fluid hct is input to the machine.Optia uses the input replacement fluid hct to set a flow rate of the replace pump to meet the final target hct.If the input replacement fluid hct is incorrect, optia may report that the target patient hct was reached when this is not the case.In this case, if the replacement fluid had an actual hematocrit that was higher than 60%, optia may have been returning more cells than it expects.It is important to ensure accurate replacement fluid hematocrit is entered to the machine when performing an rbcx procedure.Dlog analysis showed the packing factor remained at 20 throughout the procedure.Packing factor is dependent on the centrifuge speed (rpm) and the inlet flow rate (q_in) and, in optia, can be calculated by the following equation: pf = (1/7427)*(rpm^2)/(q_in) the inlet flow rate was maintained between 40 and 51 ml/min during this procedure.To maintain a packing factor of 20 at these flow rates the centrifuge rpm was maintained within the range 2437 and 2753.No abnormalities were found with the centrifuge or flow rate behavior.No alarms were raised to suggest possible issues with the centrifuge rpm or inlet flow rate.On a systems level machine performed as expected when controlling inlet flow rate and centrifuge rpm to maintain the packing factor.As a secondary observation, review of the aim system images shows the images appear bright and blurry.The bright and blurry aim image did not have any effect on the outcome of this procedure.During rbcx, the aim system has no control over the positioning of the interface.It only monitors for a high interface where cells may exit through the plasma port.The rbc detector is also activated and is programmed to detect cells in the plasma line from the centrifuge.Rbc detector signals were maintained within the expected range throughout this procedure.A bright and blurry aim image can be caused by a dirty aperture plate or aim system strobe brightness out of calibration.Residue on the aperture plate can cause light from the aim system strobe to diffuse and cause a bright image as observed.It is recommended to wipe the surface of the aperture plate with only water and a gauze pad or soft, lint free cloth.Refer to the operator¿s manual for detailed instructions of filler cleaning.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the adverse reaction experienced by the customer.Per follow-up with the customer, the entered hematocrit was 30% but the one received during the running was 28.5%.The hematocrit that came back that night was 38.7% after the procedure was completed.They reported they didn't update the entered hematocrit when they received the day-of results because they came back 2hrs after procedure start time, the operator did not remember to change it.An hgs performed was 2 days after the procedure 2/27.Per the customer, they¿re not alleging the device caused the incident, but more patient¿s own condition.According to the aabb circular of information for the use of human blood components, various red-cell-containing components have different hematocrit ranges.On april 20, terumo bct clinical specialist reached out to the customer and received answers to the following questions: 1.What kind of replacement rbcs did they use for this procedure (i.E whole blood derived, apheresis, washed rbcs, cryopreserved, thawed rbcs).All they are irradiated, sickle cell hemoglobin s (-) 2.Did they performed hct check on any of the units? no.This is done by the blood bank and it is a average of 60%.3.Did they happen to check the hct in the waste bag by any chance? no a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Investigation is in process.A follow up report will be provided.

Event Description

The customer called to report a sickle cell patient who had symptoms of a stroke approximately 30-40 min post red blood cell exchange procedure while the physician was removing the internal jugular (ij) catheter.The patient felt dizzy with shortness of breath, and was unable to move his legs.He was given 500 ml normal saline and had a ct scan which was negative.He was unable to move one of his legs so he was admitted to the hospital.The patient received 50 mg of oral benadryl and 650 mg of tylenol prior to the procedure, and another 3 gm of calcium gluconate in 200 ml of normal saline during the procedure.The patient had a history of stroke.It was reported that the patient recovered from the new symptoms he experienced when he had the incident.Per the customer, the patient¿s post hematocrit (hct) was higher a day after the procedure.The exchange set is not available for return for evaluation.

Event Description

The customer called to report a sickle cell patient who had symptoms of a stroke approximately 30-40 min post red blood cell exchange procedure while the physician was removing the internal jugular (ij) catheter.The patient felt dizzy with shortness of breath, and was unable to move his legs.He was given 500 ml normal saline and had a ct scan which was negative.He was unable to move one of his legs so he was admitted to the hospital.The patient received 50 mg of oral benadryl and 650 mg of tylenol prior to the procedure, and another 3 gm of calcium gluconate in 200 ml of normal saline during the procedure.The patient had a history of stroke.It was reported that the patient recovered from the new symptoms he experienced when he had the incident.Per the customer, the patient¿s post hematocrit (hct) was higher a day after the procedure.The exchange set is not available for return for evaluation.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the dlog confirms that the operator entered the patient hct of 30% at the start of the procedure and did not change this value throughout the procedure.The customer reported that an actual patient hct reading of 28.5% came back during the run, which is slightly lower than the input value.It is essential to enter accurate data when performing an rbcx procedure.Small errors in the data entered can result in large deviations in the expected outcome.In rbcx the patient hematocrit is used by the system to estimate the fraction of cells remaining (fcr), final patient hematocrit, replacement volume used, and it influences the flow rate of the plasma and replace pumps.Since the entered hematocrit was higher than actual, the system based its calculations on a higher rbc volume entering the system than actual, possibly providing inaccurate estimates of final hct and fcr.It is recommended to have the correct patient data values from the start of the procedure.If it is necessary to update blood counts mid procedure, the operator can update the entered patient hct by pausing the procedure and touching the ¿run¿ menu button and ¿exchange status¿ tab.Here the operator can modify the patient hematocrit parameter to the updated value before resuming the procedure.The customer reported that a patient post (hct) taken at 18:42 was 38.7%.Dlog analysis did not return a clear root cause for the higher post hct than the machine expected.An incorrect estimate of the final patient hct can also occur if an incorrect replacement fluid hct is input to the machine.Optia uses the input replacement fluid hct to set a flow rate of the replace pump to meet the final target hct.If the input replacement fluid hct is incorrect, optia may report that the target patient hct was reached when this is not the case.In this case, if the replacement fluid had an actual hematocrit that was higher than 60%, optia may have been returning more cells than it expects.It is important to ensure accurate replacement fluid hematocrit is entered to the machine when performing an rbcx procedure.Dlog analysis showed the packing factor remained at 20 throughout the procedure.Packing factor is dependent on the centrifuge speed (rpm) and the inlet flow rate (q_in) and, in optia, can be calculated by the following equation: pf = (1/7427)*(rpm^2)/(q_in) the inlet flow rate was maintained between 40 and 51 ml/min during this procedure.To maintain a packing factor of 20 at these flow rates the centrifuge rpm was maintained within the range 2437 and 2753.No abnormalities were found with the centrifuge or flow rate behavior.No alarms were raised to suggest possible issues with the centrifuge rpm or inlet flow rate.On a systems level machine performed as expected when controlling inlet flow rate and centrifuge rpm to maintain the packing factor.As a secondary observation, review of the aim system images shows the images appear bright and blurry.The bright and blurry aim image did not have any effect on the outcome of this procedure.During rbcx, the aim system has no control over the positioning of the interface.It only monitors for a high interface where cells may exit through the plasma port.The rbc detector is also activated and is programmed to detect cells in the plasma line from the centrifuge.Rbc detector signals were maintained within the expected range throughout this procedure.A bright and blurry aim image can be caused by a dirty aperture plate or aim system strobe brightness out of calibration.Residue on the aperture plate can cause light from the aim system strobe to diffuse and cause a bright image as observed.It is recommended to wipe the surface of the aperture plate with only water and a gauze pad or soft, lint free cloth.Refer to the operator¿s manual for detailed instructions of filler cleaning.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the adverse reaction experienced by the customer.Per follow-up with the customer, the entered hematocrit was 30% but the one received during the running was 28.5%.The hematocrit that came back that night was 38.7% after the procedure was completed.They reported they didn't update the entered hematocrit when they received the day-of results because they came back 2hrs after procedure start time, the operator did not remember to change it.An hgs performed was 2 days after the procedure (b)(6).Per the customer, they¿re not alleging the device caused the incident, but more patient¿s own condition.According to the aabb circular of information for the use of human blood components, various red-cell-containing components have different hematocrit ranges.On (b)(6), terumo bct clinical specialist reached out to the customer and received answers to the following questions: 1.What kind of replacement rbcs did they use for this procedure (i.E whole blood derived, apheresis, washed rbcs, cryopreserved, thawed rbcs).All they are irradiated, sickle cell hemoglobin s (-) 2.Did they performed hct check on any of the units? no.This is done by the blood bank and it is a average of 60%.3.Did they happen to check the hct in the waste bag by any chance? no a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Root cause: a root cause assessment was performed for the elevated post hematocrit.Review of the run data file confirms that the operator entered the replacement hct of 60%.The system¿s ability to achieve the target hct and target fcr is greatly dependent on the operator correctly entering the patient hct, replacement fluid hct, and target hct.Based on the clinical findings and the dlog analysis, a definitive root cause for the increase in the patient¿s post hct could not be determined but it is likely due to one or a combination of the possible causes listed below: * an inaccurate entry of the average replacement fluid that was lower than the actual value.* centrifuge rpm too low resulted in low collect hematocrit.A root cause assessment was performed for adverse reaction.Based on the clinical findings and the dlog analysis, a definitive root cause for the adverse reaction could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient¿s underlying disease state.* hyperviscosity due to an ineffective therapy.A root cause assessment was performed for the bright and blurry aim images.Based on the dlog analysis, a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * a dirty aperture plate * aim system strobe brightness out of calibration.

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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

16404109

MDR Text Key

309886822

Report Number

1722028-2023-00063

Device Sequence Number

Product Code

LKN

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

BK150251

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Health Professional

Reporter Occupation

Other Health Care Professional

Type of Report

Initial,Followup,Followup,Followup

Report Date

02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

02/20/2023

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Catalogue Number

4122201

Device Lot Number

2211296141

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Date Manufacturer Received

05/19/2023

Was Device Evaluated by Manufacturer?

Date Device Manufactured

11/29/2022

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Hospitalization;

Patient Age

27 YR

Patient Sex

Male

Patient Weight

105 KG

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

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