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); Air/Gas in Device (4062)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned a used optia set for investigation.Initial observations noted the presence of blood throughout the set.No air bubbles were observed in the flow path beyond the last point of detection (none were identified in the return pump header tubing, return pressure sensor diaphragm, return saline line or return line).The male luer on the return line was uncapped upon receipt of the set and thus some air (approximately 8cm) was noted between the return line luer and blue pinch clamp, which was noted to be in the closed position.Blood was noted in the return line from the closed blue return line pinch clamp to the cassette.The set was examined for evidence of clumping/clotting however none was found.The reservoir was noted to be 50% full of blood and some air bubbles were noted in the lower reservoir, which may have interfered with the lower level sensor during the run.Additionally, some air was also noted in the cassette flow path between the lower reservoir and return pump header tubing (approximately 7cm).Witness marks on the lower hex components indicated that the set was loaded optimally.The set was inspected for kinks, leaks and misassemblies, however none were found.It was not possible to recreate the alarm experienced by the customer.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during a red blood cell exchange procedure, they noted the presence of air bubbles in the return channel, which triggered the them to immediately stop the procedure and change the kit.The patient was stable and able to go home following the procedure.Patient identifier is not available at this time.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.

Event Description

The customer reported that during a red blood cell exchange procedure, they noted the presence of air bubbles in the return channel, which triggered the them to immediately stop the procedure and change the kit.The patient was stable and able to go home following the procedure.Patient identifier is not available at this time.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 h.6 and h.10.Investigation: the customer returned a used optia set for investigation.Initial observations noted the presence of blood throughout the set.No air bubbles were observed in the flow path beyond the last point of detection (none were identified in the return pump header tubing, return pressure sensor diaphragm, return saline line or return line).The male luer on the return line was uncapped upon receipt of the set and thus some air (approximately 8cm) was noted between the return line luer and blue pinch clamp, which was noted to be in the closed position.Blood was noted in the return line from the closed blue return line pinch clamp to the cassette.The set was examined for evidence of clumping/clotting however none was found.The reservoir was noted to be 50% full of blood and some air bubbles were noted in the lower reservoir, which may have interfered with the lower level sensor during the run.Additionally, some air was also noted in the cassette flow path between the lower reservoir and return pump header tubing (approximately 7cm).Witness marks on the lower hex components indicated that the set was loaded optimally.The set was inspected for kinks, leaks and misassemblies, however none were found.It was not possible to recreate the alarm experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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.No signals in the rdf that indicate any issues that would cause air to end up in the reservoir.There were a total of 44 'inlet pressure was too low' alarms.It is possible if the patient access was not secure that air could have entered the cassette.However air should typically be vented when it enters the reservoir and end up in the vent bag.The system has two different safety mechanisms to ensure that air is not returned to the patient.The system has the air detection in the lower level reservoir sensor and there is also the return line air detector.Neither of these detected that there was air.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.10.Investigation: the customer returned a used optia set for investigation.Initial observations noted the presence of blood throughout the set.No air bubbles were observed in the flow path beyond the last point of detection (none were identified in the return pump header tubing, return pressure sensor diaphragm, return saline line or return line).The male luer on the return line was uncapped upon receipt of the set and thus some air (approximately 8cm) was noted between the return line luer and blue pinch clamp, which was noted to be in the closed position.Blood was noted in the return line from the closed blue return line pinch clamp to the cassette.The set was examined for evidence of clumping/clotting however none was found.The reservoir was noted to be 50% full of blood and some air bubbles were noted in the lower reservoir, which may have interfered with the lower level sensor during the run.Additionally, some air was also noted in the cassette flow path between the lower reservoir and return pump header tubing (approximately 7cm).Witness marks on the lower hex components indicated that the set was loaded optimally.The set was inspected for kinks, leaks and misassemblies, however none were found.It was not possible to recreate the alarm experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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 procedure, they noted the presence of air bubbles in the return channel, which triggered the them to immediately stop the procedure and change the kit.The patient was stable and able to go home following the procedure.Patient identifier is not available at this time.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.

Event Description

The customer reported that during a red blood cell exchange procedure, they noted the presence of air bubbles in the return channel, which triggered the them to immediately stop the procedure and change the kit.The patient was stable and able to go home following the procedure.In accordance with eu personal data protection laws, the patient identifier is not available.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: the customer returned a used optia set for investigation.Initial observations noted the presence of blood throughout the set.No air bubbles were observed in the flow path beyond the last point of detection (none were identified in the return pump header tubing, return pressure sensor diaphragm, return saline line or return line).The male luer on the return line was uncapped upon receipt of the set and thus some air (approximately 8cm) was noted between the return line luer and blue pinch clamp, which was noted to be in the closed position.Blood was noted in the return line from the closed blue return line pinch clamp to the cassette.The set was examined for evidence of clumping/clotting however none was found.The reservoir was noted to be 50% full of blood and some air bubbles were noted in the lower reservoir, which may have interfered with the lower level sensor during the run.Additionally, some air was also noted in the cassette flow path between the lower reservoir and return pump header tubing (approximately 7cm).Witness marks on the lower hex components indicated that the set was loaded optimally.The set was inspected for kinks, leaks and misassemblies, however none were found.It was not possible to recreate the alarm experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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.No signals in the rdf that indicate any issues that would cause air to end up in the reservoir.There were a total of 44 'inlet pressure was too low' alarms.It is possible if the patient access was not secure that air could have entered the cassette.However air should typically be vented when it enters the reservoir and end up in the vent bag.The system has two different safety mechanisms to ensure that air is not returned to the patient.The system has the air detection in the lower level reservoir sensor and there is also the return line air detector.Neither of these detected that there was air.Root cause: 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.

• 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: 15321462
• MDR Text Key: 303415417
• Report Number: 1722028-2022-00289
• Device Sequence Number: 1
• Product Code: GKT
• 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: 08/30/2022

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 Expiration Date: 09/01/2023
• Device Catalogue Number: 10223
• Device Lot Number: 2109163130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 12/15/2022; 02/07/2023
• Supplement Dates FDA Received: 12/05/2022; 12/27/2022; 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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