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

Model Number 10220

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

Lot number, manufacture and expiry date are not available at this time.Investigation: the customer reported the following alarms: rbc calibration error, centrifuge exceed limit, return pressure, replacement fluid not detected, cells detected in plasma line in centrifuge, patient fb may be 5% lower than reported, replacement fluid not detected, 10% lower than reported and then the 15% lower than reported.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a red blood cell exchange (rbcx) procedure they received a "fluid balance may be 15% lover than reported alarm and were not able to continue the procedure.Terumo bct customer support indicated that the patient would have to be disconnected and that the reason for the alarm was the system did not detect the correct fb in the reservoir and the issue was not resolved.Per the operator, there was only one time she had air in the line from the replacement fluid not detected alarm.The other times the fluid was going in.The physician at the customer site indicated intent to start the procedure over again with a new set, terumo bct customer support was contacted again for guidance.The patient hematocrit (hct) now was 38%.A new lab was run and it was 38% now from 25% earlier.The physician wanted a fcr of 30%, end hct of 28%.Per the customer, they use a blood prime for their procedures.They take 1 unit and test it and then use that hct for the replacement hct of all of their replacement units.They normally use 42%, but she said in this case they would use 45%.Upon follow-up terumo bct customer support suggested performing a depletion/exchange.They used a beginning patient hct of 35 and replacement hct of 50%, minimum hct of 28, target hct of 28, replacement 1750 and the fcr calculated at 38%.The physician's main concern was using more blood and getting the patient's hct down.Patient id, age and outcome are not available at this time.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, b.5, h.6 and h.10.Manufacture and expiry date are not available at this time.Investigation: the customer reported the following alarms: rbc calibration error, centrifuge exceed limit, return pressure, replacement fluid not detected, cells detected in plasma line in centrifuge, patient fb may be 5% lower than reported, replacement fluid not detected, 10% lower than reported and then the 15% lower than reported.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 that during a red blood cell exchange (rbcx) procedure they received a "fluid balance may be 15% lover than reported alarm and were not able to continue the procedure.Terumo bct customer support indicated that the patient would have to be disconnected and that the reason for the alarm was the system did not detect the correct fb in the reservoir and the issue was not resolved.Per the operator, there was only one time she had air in the line from the replacement fluid not detected alarm.The other times the fluid was going in.The physician at the customer site indicated intent to start the procedure over again with a new set, terumo bct customer support was contacted again for guidance.The patient hematocrit (hct) now was 38%.A new lab was run and it was 38% now from 25% earlier.The physician wanted a fcr of 30%, end hct of 28%.Per the customer, they use a blood prime for their procedures.They take 1 unit and test it and then use that hct for the replacement hct of all of their replacement units.They normally use 42%, but she said in this case they would use 45%.Upon follow-up terumo bct customer support suggested performing a depletion/exchange.They used a beginning patient hct of 35 and replacement hct of 50%, minimum hct of 28, target hct of 28, replacement 1750 and the fcr calculated at 38%.The physician's main concern was using more blood and getting the patient's hct down.Patient id was not available from the customer.The disposables set is not available for return because it was discarded by the customer.

Event Description

The customer reported that during a red blood cell exchange (rbcx) procedure they received a "fluid balance may be 15% lower than reported alarm and were not able to continue the procedure.Terumo bct customer support indicated that the patient would have to be disconnected and that the reason for the alarm was the system did not detect the correct fb in the reservoir and the issue was not resolved.Per the operator, there was only one time she had air in the line from the replacement fluid not detected alarm.The other times the fluid was going in.The physician at the customer site indicated intent to start the procedure over again with a new set, terumo bct customer support was contacted again for guidance.The patient hematocrit (hct) now was 38%.A new lab was run and it was 38% now from 25% earlier.The physician wanted a fcr of 30%, end hct of 28%.Per the customer, they use a blood prime for their procedures.They take 1 unit and test it and then use that hct for the replacement hct of all of their replacement units.They normally use 42%, but she said in this case they would use 45%.Upon follow-up terumo bct customer support suggested performing a depletion/exchange.They used a beginning patient hct of 35 and replacement hct of 50%, minimum hct of 28, target hct of 28, replacement 1750 and the fcr calculated at 38%.The physician's main concern was using more blood and getting the patient's hct down.Patient id was not available from the customer.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Manufacture and expiry date are not available at this time.Investigation: the customer reported the following alarms: rbc calibration error, centrifuge exceed limit, return pressure, replacement fluid not detected, cells detected in plasma line in centrifuge, patient fb may be 5% lower than reported, replacement fluid not detected, 10% lower than reported and then the 15% lower than reported.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search indicated there were no other reported occurrences of post hematocrit increase on this lot worldwide.Review of the run data file (rdf) and associated images does not show a clear root cause for the volume discrepancy detected by optia.Signals in the reservoir suggest the reservoir was seeing less fluid than expected.The patient fluid balance may be lower than reported alarm is activated when the reservoir level sensors detect a greater than 10% accumulated fluid error.This alarm can be caused by an obstructed replace line or an obstructed plasma line.In this case, the level sensors detected enough volume discrepancy to lead to the run ending patient¿s fluid balance may be 15% lower than reported alarm.There is also no clear root cause for the higher hct than expected reported by the customer.When entering patient information and replace fluid data ensure it is accurate.The rg ratios detected some cells flowing through the plasma line at 1.4 minutes into procedure.The root cause for this spill over is not clear.It may be related to cell dynamics as the interface was forming early in procedure.Readings were within the expected range for the rest of the procedure.The operator did not enter semi-automatic mode or turn off the rbc detector during this procedure.In this procedure, the issue may have been related to variations in pump stroke volume due to variations in the tubing set.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a red blood cell exchange (rbcx) procedure they received a "fluid balance may be 15% lover than reported alarm and were not able to continue the procedure.Terumo bct customer support indicated that the patient would have to be disconnected and that the reason for the alarm was the system did not detect the correct fb in the reservoir and the issue was not resolved.Per the operator, there was only one time she had air in the line from the replacement fluid not detected alarm.The other times the fluid was going in.The physician at the customer site indicated intent to start the procedure over again with a new set, terumo bct customer support was contacted again for guidance.The patient hematocrit (hct) now was 38%.A new lab was run and it was 38% now from 25% earlier.The physician wanted a fcr of 30%, end hct of 28%.Per the customer, they use a blood prime for their procedures.They take 1 unit and test it and then use that hct for the replacement hct of all of their replacement units.They normally use 42%, but she said in this case they would use 45%.Upon follow-up terumo bct customer support suggested performing a depletion/exchange.They used a beginning patient hct of 35 and replacement hct of 50%, minimum hct of 28, target hct of 28, replacement 1750 and the fcr calculated at 38%.The physician's main concern was using more blood and getting the patient's hct down.Patient id was not available from the customer.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Manufacture and expiry date are not available at this time.Invesitgation: the customer reported the following alarms: rbc calibration error, centrifuge exceed limit, return pressure, replacement fluid not detected, cells detected in plasma line in centrifuge, patient fb may be 5% lower than reported, replacement fluid not detected, 10% lower than reported and then the 15% lower than reported.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search indicated there were no other reported occurrences of post hematocrit increase on this lot worldwide.Review of the run data file (rdf) and associated images does not show a clear root cause for the volume discrepancy detected by optia.Signals in the reservoir suggest the reservoir was seeing less fluid than expected.The patient fluid balance may be lower than reported alarm is activated when the reservoir level sensors detect a greater than 10% accumulated fluid error.This alarm can be caused by an obstructed replace line or an obstructed plasma line.In this case, the level sensors detected enough volume discrepancy to lead to the run ending patient¿s fluid balance may be 15% lower than reported alarm.There is also no clear root cause for the higher hct than expected reported by the customer.When entering patient information and replace fluid data ensure it is accurate.The rg ratios detected some cells flowing through the plasma line at 1.4 minutes into procedure.The root cause for this spill over is not clear.It may be related to cell dynamics as the interface was forming early in procedure.Readings were within the expected range for the rest of the procedure.The operator did not enter semi-automatic mode or turn off the rbc detector during this procedure.In this procedure, the issue may have been related to variations in pump stroke volume due to variations in the tubing set.Root cause: a root cause assessment was performed for the increase in the patient's post hematocrit.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * replacement fluid hematocrit entry error which may have left the patient with end hematocrit higher than expected resulting in blood component elevation.* rbcx centrifuge rpm was too low resulting in lower collect hematocrit and higher patient hematocrit.* operator entering a much lower than actual hct of the rbc unit on the custom prime screen result.* variations in pump stroke volume due to variations in the tubing set.* suboptimal loading resulted in plasma line occlusion causing diversion of plasma into the rbc waste bag.

• 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: 13758782
• MDR Text Key: 287926551
• Report Number: 1722028-2022-00082
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• 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: Followup,Followup,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Device Lot Number: 2110203230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 47 KG