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

Catalog Number 4123201

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

Patient Problem Air Embolism (1697)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer submitted five photographs to aid the investigation.The images show the set loaded on the optia device and confirm the presence of air bubbles in the blood warmer tubing.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 reported to terumo bct customer support that during the last 30 minutes of an autologous stem cell collection procedure air was observed after the warmer in the warming tubing.The procedure was stopped and the air was removed before reaching the patient.The leur connections were tight.No clotting was visible, but clumping was observed in the collection line.The customer declined to provide patient information.The collection 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.Investigation: the customer submitted five photographs to aid the investigation.The images show the set loaded on the optia device and confirm the presence of air bubbles in the blood warmer tubing.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during the last 30 minutes of an autologous stem cell collection procedure air was observed after the warmer in the warming tubing.The procedure was stopped and the air was removed before reaching the patient.The leur connections were tight.No clotting was visible, but clumping was observed in the collection line.The customer declined to provide patient information.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

10.Investigation: the customer submitted five photographs to aid the investigation.The images show the set loaded on the optia device and confirm the presence of air bubbles in the blood warmer tubing.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the rdf and associated images does not show a clear root cause for the reported 3 inches of air in the blood warmer tubing of the return line.The rdf shows there was no alarm raised from return line air detector (rlad) for air in the return line.The rlad is located on the bottom left corner of the return pump, inside the return pump housing.It will constantly monitor for air flowing downstream of the return pump during procedural operation.If air is detected by this sensor during the procedure, an alarm will raise, and the pumps will be paused in order to perform air removal.If the rlad does not detect any air move past it but the operator confirms there is air in the blood warmer tubing it is possible the air entered the tubing from the luer connection between the blood warmer tubing and the return line.It was confirmed with the rdf that the operator configured optia to use a blood warmer of 40 ml during this procedure.It is possible for air to enter the blood warmer tubing if the luer connection from the return line to the blood warmer tubing is placed 20 inches higher than the patient access site and/or if it is not tightly closed.In the case which air is introduced from the site of this luer connection then it cannot be detected by the rlad since it is downstream of the sensor near the return pump.Therefore, it is important to take the appropriate actions to prevent air from entering the blood warmer tubing.To do this, the operator should ensure the luer connection from the return line to the blood warmer tubing is tight and put the luer connection no higher than 20 in (50 cm) above the return access site.Aim images showed evidence of clumping at the channel connector at roughly 126 minutes into the procedure.In addition, signals from rbc detector displayed a spiking behavior throughout this procedure.In cmnc the rbc detector does not directly affect the product being collected throughout the procedure but it does maintain readings of the cellular content in the collect line throughout the procedure.In general, high readings correlate with a higher cell content and low readings correlate with a low cell content.When there are large correlations it is indicative that the collected product is varying in cell density.This can correlated with clumping in the channel connector.Clumping at the channel connector can interfere with the proper separation of cells and lead to varying cell content being collected.The customer reported there was no obvious clumping in the channel or return reservoir.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.Therefore, every procedure should be observed for clumping in the connector, particularly at the interface before the collect port, and the collect port.If a clump is observed at these locations, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.If the operator continues to notice clumping during the run, they may consider running the procedures at lower inlet:ac ratio.Monitor the connector and the collect port for clumping.If a clump is seen, it is best to address it immediately.If the clump persists, it may become a clot, which is much more difficult and sometimes impossible to eliminate.In this procedure the operator decreased the inlet:ac ratio to 8 at 48 min until roughly 72 min.The operator lowered the ac ratio to 6 until 97 minutes when this was brought to 8 once more.After 108 minutes of procedure the operator lowered the ac ratio to 6 for the remainder of the procedure.On a systems level no issue with this optia was identified.All safety systems remained in place and the appropriate alarms were raised.The device was found to be operating as expected.There were no images or report of air being present in the idl kit return line, only in the blood warmer tubing.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during the last 30 minutes of an autologous stem cell collection procedure air was observed after the warmer in the warming tubing.The procedure was stopped and the air was removed before reaching the patient.The leur connections were tight.No clotting was visible, but clumping was observed in the collection line.The customer declined to provide patient information.Patients gender and weight were obtained from the run data file (rdf).The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported to terumo bct customer support that during the last 30 minutes of an autologous stem cell collection procedure air was observed after the warmer in the warming tubing.The procedure was stopped and the air was removed before reaching the patient.The customer stated the procedure lasted 315 minutes and the air in the return line occurred within the last 30 minutes.There were no rlad alarms for this event.The leur connections were tight.No clotting was visible, but clumping was observed in the collection line.The customer declined to provide patient information.Patient¿s gender and weight were obtained from the run data file (rdf).The collection 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 b.5, h.6 and h.11 and corrected information in a.3a, a.4.B.6 and h.11.Investigation: the customer submitted five photographs to aid the investigation.The images show the set loaded on the optia device and confirm the presence of air bubbles in the blood warmer tubing.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the dlog and associated images does not show a clear root cause for the report of air in the blood warmer tubing of the return line removed during 3 separate times this procedure.The dlog shows there was no alarm raised from return line air detector (rlad) for air in the return line.The rlad is located on the bottom left corner of the return pump, inside the return pump housing.It will constantly monitor for air flowing downstream of the return pump during procedural operation.If air is detected by this sensor during the procedure, an alarm will raise, and the pumps will be paused in order to perform air removal.If the rlad does not detect any air move past it but the operator confirms there is air in the blood warmer tubing it is possible the air entered the tubing from the luer connection between the blood warmer tubing and the return line.It was confirmed with the dlog that the operator configured optia to use a blood warmer of 40 ml during this procedure.It is possible for air to enter the blood warmer tubing if the luer connection from the return line to the blood warmer tubing is placed 20 inches higher than the patient access site and/or if it is not tightly closed.In the case which air is introduced from the site of this luer connection then it cannot be detected by the rlad since it is downstream of the sensor near the return pump.Therefore, it is important to take the appropriate actions to prevent air from entering the blood warmer tubing.To do this, the operator should ensure the luer connection from the return line to the blood warmer tubing is tight and put the luer connection no higher than 20 in (50 cm) above the return access site.Aim images showed evidence of some clumping at the channel connector throughout this procedure.In addition, signals from rbc detector displayed a spiking behavior throughout this procedure.Clumping at the channel connector can interfere with the proper separation of cells and lead to varying cell content being collected.The customer reported there was presence of clumping the collect line.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.Therefore, every procedure should be observed for clumping in the connector, particularly at the interface before the collect port, and the collect port.If a clump is observed at these locations, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.If the operator continues to notice clumping during the run, they may consider running the procedures at lower inlet:ac ratio.Monitor the connector and the collect port for clumping.If a clump is seen, it is best to address it immediately.If the clump persists, it may become a clot, which is much more difficult and sometimes impossible to eliminate.In this procedure the operator decreased the inlet:ac ratio from 8 to 6 at 55 min into the procedure and maintained it here for the rest of the procedure.On a systems level no issue with this optia was identified.All safety systems remained in place and the appropriate alarms were raised.The device was found to be operating as expected.The images provided with this report confirm air in the blood warmer tubing.There was no report of air in the return line of the idl set, prior to the blood warmer tubing.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: the customer submitted five photographs to aid the investigation.The images show the set loaded on the optia device and confirm the presence of air bubbles in the blood warmer tubing.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the dlog and associated images does not show a clear root cause for the report of air in the blood warmer tubing of the return line removed during 3 separate times this procedure.The dlog shows there was no alarm raised from return line air detector (rlad) for air in the return line.The rlad is located on the bottom left corner of the return pump, inside the return pump housing.It will constantly monitor for air flowing downstream of the return pump during procedural operation.If air is detected by this sensor during the procedure, an alarm will raise, and the pumps will be paused in order to perform air removal.If the rlad does not detect any air move past it but the operator confirms there is air in the blood warmer tubing it is possible the air entered the tubing from the luer connection between the blood warmer tubing and the return line.It was confirmed with the dlog that the operator configured optia to use a blood warmer of 40 ml during this procedure.It is possible for air to enter the blood warmer tubing if the luer connection from the return line to the blood warmer tubing is placed 20 inches higher than the patient access site and/or if it is not tightly closed.In the case which air is introduced from the site of this luer connection then it cannot be detected by the rlad since it is downstream of the sensor near the return pump.Therefore, it is important to take the appropriate actions to prevent air from entering the blood warmer tubing.To do this, the operator should ensure the luer connection from the return line to the blood warmer tubing is tight and put the luer connection no higher than 20 in (50 cm) above the return access site.Aim images showed evidence of some clumping at the channel connector throughout this procedure.In addition, signals from rbc detector displayed a spiking behavior throughout this procedure.Clumping at the channel connector can interfere with the proper separation of cells and lead to varying cell content being collected.The customer reported there was presence of clumping the collect line.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.Therefore, every procedure should be observed for clumping in the connector, particularly at the interface before the collect port, and the collect port.If a clump is observed at these locations, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.If the operator continues to notice clumping during the run, they may consider running the procedures at lower inlet:ac ratio.Monitor the connector and the collect port for clumping.If a clump is seen, it is best to address it immediately.If the clump persists, it may become a clot, which is much more difficult and sometimes impossible to eliminate.In this procedure the operator decreased the inlet:ac ratio from 8 to 6 at 55 min into the procedure and maintained it here for the rest of the procedure.On a systems level no issue with this optia was identified.All safety systems remained in place and the appropriate alarms were raised.The device was found to be operating as expected.The images provided with this report confirm air in the blood warmer tubing.There was no report of air in the return line of the idl set, prior to the blood warmer tubing.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause of air in the blood warmer tubing could not be determined but it is likely due to one or a combination of the possible causes listed below: luer connection from the return line to the blood warmer is placed too high.Luer connection from the return line to the blood warmer is not tightly closed.Blood warmer equipment creates outgassing in the tubing when warming of the fluid passing through the warmer such as cold replacement fluid clumping in the channel.

Event Description

The customer reported to terumo bct customer support that during the last 30 minutes of an autologous stem cell collection procedure air was observed after the warmer in the warming tubing.The procedure was stopped and the air was removed before reaching the patient.The customer stated the procedure lasted 315 minutes and the air in the return line occurred within the last 30 minutes.There were no rlad alarms for this event.The leur connections were tight.No clotting was visible, but clumping was observed in the collection line.The customer declined to provide patient information.Patient¿s gender and weight were obtained from the run data file (rdf).The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 18383631
• MDR Text Key: 331487142
• Report Number: 1722028-2023-00421
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4123201
• Device Lot Number: 2306236141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/02/2024; 02/29/2024; 04/26/2024; Not provided
• Supplement Dates FDA Received: 01/15/2024; 03/04/2024; 05/14/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 12 KG