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

Catalog Number 10220

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

Patient Problem Hemolysis (1886)

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer called terumo bct customer support during red blood cell exchange (rbcx) procedure with cells detected in plasma line in centrifuge because the plasma was red tinged.Terumo bct customer support had the customer pause the procedure and notify the physician at which point the physician wanted her to continue with the procedure.Patient information and outcome are unknown at this time.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 lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.A photograph of the cassette was provided to tbct clinical support which confirmed the plasma in the cassette was red and there was hemolysis.No obvious misassemblies, kinks, or occlusions can be observed in the provided image.A disposable complaint history search was not performed for this lot as the customer did not provide the lot number.Investigation is in process, a follow-up report will be provided.

Event Description

The customer called terumo bct customer support during red blood cell exchange (rbcx) procedure with cells detected in plasma line in centrifuge because the plasma was red tinged.Terumo bct customer support had the customer pause the procedure and notify the physician at which point the physician wanted her to continue with the procedure.Patient information and outcome are unknown at this time.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 lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.A photograph of the cassette was provided to tbct clinical support which confirmed the plasma in the cassette was red and there was hemolysis.No obvious misassemblies, kinks, or occlusions can be observed in the provided image.A disposable complaint history search was not performed for this lot as the customer did not provide the lot number.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.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

Event Description

The customer called terumo bct customer support during red blood cell exchange (rbcx) procedure with cells detected in plasma line in centrifuge because the plasma was red tinged.Terumo bct customer support had the customer pause the procedure and notify the physician at which point the physician wanted her to continue with the procedure.Patient information and outcome were not provided by the customer.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

H.10.Investigation: per follow-up with the customer, a custom prime was not performed.The age of the rbc's is unknown.It is also unknown if the blood product used was collected on a tbct device.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.A photograph of the cassette was provided to tbct clinical support which confirmed the plasma in the cassette was red and there was hemolysis.No obvious misassemblies, kinks, or occlusions can be observed in the provided image.A disposable complaint history search was not performed for this lot as the customer did not provide the lot number.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.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

Event Description

The customer called terumo bct customer support 19 minutes into a red blood cell exchange (rbcx) procedure with a "cells detected in plasma line" alarm in centrifuge because the plasma was red tinged.Terumo bct customer support had the customer pause the procedure and notify the physician at which point the physician wanted her to continue with the procedure.The hematocrit (hct) of the 3 units of blood was 62.5%.Per one of the suggestions of the error code, the patient's hct was increased to 29% (by 3%) and the hct of the replacement fluid (prbc's used) was increased to 63%.Terumo customer support was called when the problem was not able to be resolved with the given suggestions.We reviewed what all had been done at that point.The appropriate priming fluids were used (acd a and ns) and the plasma line was noted to be pink tinged versus the usual yellow.The physician at the customer site was updated on the alarms, the patient's status, and that terumo has been contacted.He was given an update on the status of the patient including vs, no signs of adverse reaction, and her behavior.He stated that hemolysis can sometimes occur in sickle cell patients and instructed to continue with the treatment and to keep the patient on the unit until the post rbc exchange labs resulted.Terumo bct then proceeded with instructions on restarting.Verification of the appropriateness of the interface's position was made.It was confirmed that the rbc layer wasn't so high that rbc's are being syphoned into the plasma.The instructions that were then given were to press stop, rbc detector was disabled, the patient's hct was changed back to 26%, and then the treatment was restarted.The treatment continued and completed without any further alarms or change in patient's status.She remained awake and her usual self per the customer.Patient remained until post labs h&h, resulted and were reviewed by the physician.No further medical interventions were required.When the tubing was removed from the machine, there were no clots noted in the large band or chambers.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer called terumo bct customer support 19 minutes into a red blood cell exchange (rbcx) procedure with a "cells detected in plasma line" alarm in centrifuge because the plasma was red tinged.Terumo bct customer support had the customer pause the procedure and notify the physician at which point the physician wanted her to continue with the procedure.The hematocrit (hct) of the 3 units of blood was 62.5%.Per one of the suggestions of the error code, the patient's hct was increased to 29% (by 3%) and the hct of the replacement fluid (prbc's used) was increased to 63%.Terumo customer support was called when the problem was not able to be resolved with the given suggestions.We reviewed what all had been done at that point.The appropriate priming fluids were used (acd a and ns) and the plasma line was noted to be pink tinged versus the usual yellow.The physician at the customer site was updated on the alarms, the patient's status, and that terumo has been contacted.He was given an update on the status of the patient including vs, no signs of adverse reaction, and her behavior.He stated that hemolysis can sometimes occur in sickle cell patients and instructed to continue with the treatment and to keep the patient on the unit until the post rbc exchange labs resulted.Terumo bct then proceeded with instructions on restarting.Verification of the appropriateness of the interface's position was made.It was confirmed that the rbc layer wasn't so high that rbc's are being syphoned into the plasma.The instructions that were then given were to press stop, rbc detector was disabled, the patient's hct was changed back to 26%, and then the treatment was restarted.The treatment continued and completed without any further alarms or change in patient's status.She remained awake and her usual self per the customer.Patient remained until post labs h&h, resulted and were reviewed by the physician.No further medical interventions were required.When the tubing was removed from the machine, there were no clots noted in the large band or chambers.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per follow-up with the customer, a custom prime was not performed.The age of the rbc's is unknown.It is also unknown if the blood product used was collected on a tbct device.A photograph of the cassette was provided to tbct clinical support which confirmed the plasma in the cassette was red and there was hemolysis.No obvious misassemblies, kinks, or occlusions can be observed in the provided image.A disposable complaint history search was performed for this lot and found one report 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.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.* hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

Event Description

The customer called terumo bct customer support 19 minutes into a red blood cell exchange (rbcx) procedure with a "cells detected in plasma line" alarm in centrifuge because the plasma was red tinged.Terumo bct customer support had the customer pause the procedure and notify the physician at which point the physician wanted her to continue with the procedure.The hematocrit (hct) of the 3 units of blood was 62.5%.Per one of the suggestions of the error code, the patient's hct was increased to 29% (by 3%) and the hct of the replacement fluid (prbc's used) was increased to 63%.Terumo customer support was called when the problem was not able to be resolved with the given suggestions.We reviewed what all had been done at that point.The appropriate priming fluids were used (acd a and ns) and the plasma line was noted to be pink tinged versus the usual yellow.The physician at the customer site was updated on the alarms, the patient's status, and that terumo has been contacted.He was given an update on the status of the patient including vs, no signs of adverse reaction, and her behavior.He stated that hemolysis can sometimes occur in sickle cell patients and instructed to continue with the treatment and to keep the patient on the unit until the post rbc exchange labs resulted.Terumo bct then proceeded with instructions on restarting.Verification of the appropriateness of the interface's position was made.It was confirmed that the rbc layer wasn't so high that rbc's are being syphoned into the plasma.The instructions that were then given were to press stop, rbc detector was disabled, the patient's hct was changed back to 26%, and then the treatment was restarted.The treatment continued and completed without any further alarms or change in patient's status.She remained awake and her usual self per the customer.Patient remained until post labs h&h, resulted and were reviewed by the physician.No further medical interventions were required.When the tubing was removed from the machine, there were no clots noted in the large band or chambers.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per follow-up with the customer, a custom prime was not performed.The age of the rbc's is unknown.It is also unknown if the blood product used was collected on a tbct device.A photograph of the cassette was provided to tbct clinical support which confirmed the plasma in the cassette was red and there was hemolysis.No obvious disassemblies, kinks, or occlusions can be observed in the provided image.A disposable complaint history search was performed for this lot and found one report for similar issues on this lot.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.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

• 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: 17415434
• MDR Text Key: 320038985
• Report Number: 1722028-2023-00263
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Device Lot Number: 2301243141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• 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): Other
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 32 KG