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

Catalog Number 10226

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

Patient Problem Hemolysis (1886)

Event Date 12/12/2021

Event Type  malfunction  

Event Description

The customer reported that the operator found hemolysis at channel tubing connector during the run.The operator adjusted the inlet rate, then the procedure could be continued.Patient information and outcome are not available at this time.The disposables 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 is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.The run data file (rdf) was analyzed for this event.Review of the blogs did not indicate a conclusive root cause for the hemolysis that was noted by the operator at the channel during the run.The optia system detects red cell content through the rbc detector and will typically result in a ¿cells were detected in plasma line from centrifuge¿ alarm.This alarm did not occur in any of the three tpe procedures reviewed in the blog.Review of the images did not show anything unusual throughout the procedure.There were no other signals that would indicate hemolysis occurred during the procedure.If the hemolysis was noted at the end of the procedure when the operator unloads the kit, it could have been mistaken for rinseback.When rinseback occurs, it mixes saline with the residual blood in the channel.This can give the residual blood a light pink color which may be mistaken for hemolysis.There were no other alarms or alerts that occurred.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the operator found hemolysis at channel tubing connector during the run.The operator adjusted the inlet rate, then the procedure could be continued.Patient information and outcome are not available at this time.The disposables 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: the run data file (rdf) was analyzed for this event.Review of the dlogs did not indicate a conclusive root cause for the hemolysis that was noted by the operator at the channel during the run.The optia system detects red cell content through the rbc detector and will typically result in a ¿cells were detected in plasma line from centrifuge¿ alarm.This alarm did not occur in any of the three tpe procedures reviewed in the dlog.Review of the images did not show anything unusual throughout the procedure.There were no other signals that would indicate hemolysis occurred during the procedure.If the hemolysis was noted at the end of the procedure when the operator unloads the kit, it could have been mistaken for rinseback.When rinseback occurs, it mixes saline with the residual blood in the channel.This can give the residual blood a light pink color which may be mistaken for hemolysis.There were no other alarms or alerts that occurred.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer submitted a short 6 second video showing what appears to be hemolysis in the collect connector.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the operator found hemolysis at channel tubing connector during the run.The operator adjusted the inlet rate, then the procedure could be continued.Patient information and outcome are not available at this time.The disposables 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.Patient¿s gender and weight were obtained from the run data file (rdf).

Event Description

The customer reported that the operator found hemolysis at channel tubing connector during the run.The operator adjusted the inlet rate, then the procedure could be continued.Patient information and outcome are not available at this time.The disposables 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.Patient¿s gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information in a.3, a.4, b.5, b.6, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the dlogs did not indicate a conclusive root cause for the hemolysis that was noted by the operator at the channel during the run.The optia system detects red cell content through the rbc detector and will typically result in a ¿cells were detected in plasma line from centrifuge¿ alarm.This alarm did not occur in any of the three tpe procedures reviewed in the dlog.Review of the images did not show anything unusual throughout the procedure.There were no other signals that would indicate hemolysis occurred during the procedure.If the hemolysis was noted at the end of the procedure when the operator unloads the kit, it could have been mistaken for rinseback.When rinseback occurs, it mixes saline with the residual blood in the channel.This can give the residual blood a light pink color which may be mistaken for hemolysis.There were no other alarms or alerts that occurred.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer submitted a short 6 second video showing what appears to be hemolysis in the collect connector.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the dlogs did not indicate a conclusive root cause for the hemolysis that was noted by the operator at the channel during the run.The optia system detects red cell content through the rbc detector and will typically result in a ¿cells were detected in plasma line from centrifuge¿ alarm.This alarm did not occur in any of the three tpe procedures reviewed in the dlog.Review of the images did not show anything unusual throughout the procedure.There were no other signals that would indicate hemolysis occurred during the procedure.If the hemolysis was noted at the end of the procedure when the operator unloads the kit, it could have been mistaken for rinseback.When rinseback occurs, it mixes saline with the residual blood in the channel.This can give the residual blood a light pink color which may be mistaken for hemolysis.There were no other alarms or alerts that occurred.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer submitted a short 6 second video showing what appears to be hemolysis in the collect connector.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for hemolysis 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 patient's medication and/or medical treatment hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to pinched return line resulting in rbc¿s exposed to pressure drop in return line.Hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.The residual total risk is determined to be low.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

Event Description

The customer reported that the operator found hemolysis at channel tubing connector during the run.The operator adjusted the inlet rate, then the procedure could be continued.Patient information was not provided by the customer.Per the customer the patient was reported as 'normal' and there was no report of medical intervention.The disposables 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.Patient¿s gender and weight were obtained from the run data file (rdf).

• 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: 13314784
• MDR Text Key: 286443359
• Report Number: 1722028-2022-00025
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 10226
• Device Lot Number: 2107263130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2021
• 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 Sex: Female
• Patient Weight: 75 KG