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

Catalog Number 10223

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer during an exchange procedure, the initiation of the procedure went well.After the second cgr, the sampling pressures dropped and we had to rinse the sampling channel several times, about ten syringes.(low pressure alarms).Unfortunately, after several times, it was noticed the presence of air bubbles on the cassette (just after the first pressure sensor - at the level of the trap in the sampling tubing), preventing the smooth running of the procedure.The customer also noted the presence of air bubbles on the return channel which triggered the immediate stop of the procedure and the change of kits.There was no clinical impact on the patient.Patient information is unknown at this time.Terumo bct is awaiting return of the disposable set for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found one report for similar issues on this lot.See 1722028-2022-00289 for additional reported event.Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer during an exchange procedure, the initiation of the procedure went well.After the second cgr, the sampling pressures dropped and we had to rinse the sampling channel several times, about ten syringes.(low pressure alarms).Unfortunately, after several times, it was noticed the presence of air bubbles on the cassette (just after the first pressure sensor - at the level of the trap in the sampling tubing), preventing the smooth running of the procedure.The customer also noted the presence of air bubbles on the return channel which triggered the immediate stop of the procedure and the change of kits.There was no clinical impact on the patient.Patient information is unknown at this time.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, a.3, a.4, b.5, e.1, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found one report for similar issues on this lot.See 1722028-2022-00289 for additional reported event.The initiation of the erythrapheresis (transfusion exchange) procedure went well.After the second cgr, the sampling pressures dropped and the operator had to rinse the sampling channel several times, about ten syringes.(low pressure alarms).Unfortunately, after several times, they noticed the presence of air bubbles on the cassette (just after the first pressure sensor - at the level of the trap in the sampling tubing), preventing the smooth running of the procedure.The operator also noted the presence of air bubbles on the return channel, on the way back to the patient, which triggered the immediate stop of the procedure and the change of kits.The last point of detection had been exceeded.All luer connections were tight and the blood diversion pouch was not inflated with air.The patient was connected at the time.No air was being drawn in through the ac line/filter, and no clotting was present in the channel or return reservoir.No ancillary devices were connected to the return line.There was no medical intervention.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images did not confirm the presence of air at any point during the 85-minute rbc exchange procedure as reported in the complaint.It was noted that there were multiple pressure alarms during the run along with several pump pauses by the operator.It is possible that patient venous access challenges contributed to issues experienced during this procedure.As mentioned previously, there were numerous access pressure alarms throughout the run (26x return pressure and 2x inlet pressure alarms) along with several pump pauses induced by the operator.These events along with multiple changes to the inlet flow rate are recognized as potential contributing factors to affect the cells being removed from the connector and efficiency of the procedure.Excessive pressure alarms can directly affect removal efficiency as they cause the pumps to pause and the system to re-establish the interface, which in turn affects how well cells are being removed from the connector.Ensuring the patient access is appropriately sized, nothing is blocking the access, the inlet flow rate is not too high, and generally controlling access issues is important as these can greatly contribute to the success of a procedure.Additionally, the optia system has two safety mechanisms to detect air in the system and prevent it from being returned to the patient.The primary system is the reservoir level sensors which house the fluid before it is returned to the patient.The secondary safety mechanism is the return line air detector located on the outlet of the return pump raceway.This is an ultrasonic air detector mounted in the return pump raceway housing to detect air before it can be returned to the patient.Both safety systems were verified to be functional and did not indicate air was present in the set.Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer during an exchange procedure, the initiation of the procedure went well.After the second cgr, the sampling pressures dropped and we had to rinse the sampling channel several times, about ten syringes.(low pressure alarms).Unfortunately, after several times, it was noticed the presence of air bubbles on the cassette (just after the first pressure sensor - at the level of the trap in the sampling tubing), preventing the smooth running of the procedure.The customer also noted the presence of air bubbles on the return channel which triggered the immediate stop of the procedure and the change of kits.There was no clinical impact on the patient.Due to eu personal data protection laws, the patient information is not available from the customer.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found one report for similar issues on this lot.See 1722028-2022-00289 for additional reported event.The initiation of the erythrapheresis (transfusion exchange) procedure went well.After the second cgr, the sampling pressures dropped and the operator had to rinse the sampling channel several times, about ten syringes.(low pressure alarms).Unfortunately, after several times, they noticed the presence of air bubbles on the cassette (just after the first pressure sensor - at the level of the trap in the sampling tubing), preventing the smooth running of the procedure.The operator also noted the presence of air bubbles on the return channel, on the way back to the patient, which triggered the immediate stop of the procedure and the change of kits.The last point of detection had been exceeded.All luer connections were tight and the blood diversion pouch was not inflated with air.The patient was connected at the time.No air was being drawn in through the ac line/filter, and no clotting was present in the channel or return reservoir.No ancillary devices were connected to the return line.There was no medical intervention.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images did not confirm the presence of air at any point during the 85-minute rbc exchange procedure as reported in the complaint.It was noted that there were multiple pressure alarms during the run along with several pump pauses by the operator.It is possible that patient venous access challenges contributed to issues experienced during this procedure.As mentioned previously, there were numerous access pressure alarms throughout the run (26x return pressure and 2x inlet pressure alarms) along with several pump pauses induced by the operator.These events along with multiple changes to the inlet flow rate are recognized as potential contributing factors to affect the cells being removed from the connector and efficiency of the procedure.Excessive pressure alarms can directly affect removal efficiency as they cause the pumps to pause and the system to re-establish the interface, which in turn affects how well cells are being removed from the connector.Ensuring the patient access is appropriately sized, nothing is blocking the access, the inlet flow rate is not too high, and generally controlling access issues is important as these can greatly contribute to the success of a procedure.Additionally, the optia system has two safety mechanisms to detect air in the system and prevent it from being returned to the patient.The primary system is the reservoir level sensors which house the fluid before it is returned to the patient.The secondary safety mechanism is the return line air detector located on the outlet of the return pump raceway.This is an ultrasonic air detector mounted in the return pump raceway housing to detect air before it can be returned to the patient.Both safety systems were verified to be functional and did not indicate air was present in the set.Root cause: a root cause assessment was performed for this complaint.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: patient access was not secure that air could have entered the cassette.A failure to fully prime the return line a failure of the optia device or operator error a disposable manufacturing defect.

Event Description

Per the customer during an exchange procedure, the initiation of the procedure went well.After the second cgr, the sampling pressures dropped and we had to rinse the sampling channel several times, about ten syringes.(low pressure alarms).Unfortunately, after several times, it was noticed the presence of air bubbles on the cassette (just after the first pressure sensor - at the level of the trap in the sampling tubing), preventing the smooth running of the procedure.The customer also noted the presence of air bubbles on the return channel which triggered the immediate stop of the procedure and the change of kits.There was no clinical impact on the patient.Due to eu personal data protection laws, the patient information is not available from the customer.The collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• 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: 15352269
• MDR Text Key: 305526772
• Report Number: 1722028-2022-00294
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: 10223
• Device Lot Number: 2109163130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 49 KG