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

Catalog Number 4122201

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

Patient Problem Hemolysis (1886)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that hemolysis (cherry red) occurred in the connector and cassette and a "cells detected in the plasma line in centrifuge" alarm 3 minutes into a therapeutic plasma exchange (tpe) procedure.The customer stated that the patient had hemodialysis (hd) prior to the procedure and that this was the patient's 2nd procedure.There were no issues with the first procedure.The customer stated that the patient had chemotherapy the saturday before the procedure.The replacement fluid was mixed by rx - 5% albumin mixed with mg sulfate 7.5 meq, cagluconate 16.8 meq, kcl 15 meq and nothing else.The physician decided to have the replacement fluid tested and a post complete blood count, lactate dehydrogenase, comprehensive metabolic panel, biliribuin, and albumin levels.The patient is in stable condition.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.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and associated aim images does not show a clear root cause for the reported occurrence of red tinged plasma suspected of hemolysis.In tpe the rbc detector is actively monitoring the color of the plasma line exiting the centrifuge to identify possible cell spillover or darker than expected plasma.If the fluid in the plasma line is detected to be darker than expected, an alarm is raised.In this case there were 2 occurrences of alarm ¿cells were detected in plasma line from centrifuge¿ and 1 occurrence of ¿system continued to detect cells in plasma line from centrifuge¿.These alarms are raised when the rbc detector readings indicate the plasma content is darker than expected, suspecting a spillover condition.This may be caused if the rbc detector contained air bubble, the patient hematocrit entered was too low, fluid balance caused hematocrit to increase in the patient, inlet flow rate was too high, or hemolysis may have occurred.The procedure only lasted a total of 3 minutes before entering rinseback.Analysis of the rdf is not able to confirm the occurrence of hemolysis during this procedure.In addition, this short run time did not allow for aim images during the procedure to be saved in the rdf for analysis therefore image analysis could not be completed for this procedure.Review of the run data file showed the system to be operating as intended with the proper alarms raised.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that hemolysis (cherry red) occurred in the connector and cassette and a "cells detected in the plasma line in centrifuge" alarm 3 minutes into a therapeutic plasma exchange (tpe) procedure.The customer stated that the patient had hemodialysis (hd) prior to the procedure and that this was the patient's 2nd procedure.There were no issues with the first procedure.The customer stated that the patient had chemotherapy the saturday before the procedure.The replacement fluid was mixed by rx - 5% albumin mixed with mg sulfate 7.5 meq, cagluconate 16.8 meq, kcl 15 meq and nothing else.The physician decided to have the replacement fluid tested and a post complete blood count, lactate dehydrogenase, comprehensive metabolic panel, biliribuin, and albumin levels.The patient is in stable condition.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 (h.11).Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and associated aim images does not show a clear root cause for the reported occurrence of red tinged plasma suspected of hemolysis.In tpe the rbc detector is actively monitoring the color of the plasma line exiting the centrifuge to identify possible cell spillover or darker than expected plasma.If the fluid in the plasma line is detected to be darker than expected, an alarm is raised.In this case there were 2 occurrences of alarm ¿cells were detected in plasma line from centrifuge¿ and 1 occurrence of ¿system continued to detect cells in plasma line from centrifuge¿.These alarms are raised when the rbc detector readings indicate the plasma content is darker than expected, suspecting a spillover condition.This may be caused if the rbc detector contained air bubble, the patient hematocrit entered was too low, fluid balance caused hematocrit to increase in the patient, inlet flow rate was too high, or hemolysis may have occurred.The procedure only lasted a total of 3 minutes before entering rinseback.Analysis of the rdf is not able to confirm the occurrence of hemolysis during this procedure.In addition, this short run time did not allow for aim images during the procedure to be saved in the rdf for analysis therefore image analysis could not be completed for this procedure.Review of the run data file showed the system to be operating as intended with the proper alarms raised.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 no reports for similar issues on this lot.Root cause: a root cause assessment was performed for this complaint.Review of the dlog and associated aim images does not show a clear root cause for the reported occurrence of red tinged plasma suspected of hemolysis.In tpe the rbc detector is actively monitoring the color of the plasma line exiting the centrifuge to identify possible cell spillover or darker than expected plasma.If the fluid in the plasma line is detected to be darker than expected, an alarm is raised.In this case there were 2 occurrences of alarm ¿cells were detected in plasma line from centrifuge¿ and 1 occurrence of ¿system continued to detect cells in plasma line from centrifuge¿.These alarms are raised when the rbc detector readings indicate the plasma content is darker than expected, suspecting a spillover condition.This may be caused if the rbc detector contained air bubble, the patient hematocrit entered was too low, fluid balance caused hematocrit to increase in the patient, inlet flow rate was too high, or hemolysis may have occurred.The procedure only lasted a total of 3 minutes before entering rinseback.Analysis of the dlog is not able to confirm the occurrence of hemolysis during this procedure.In addition, this short run time did not allow for aim images during the procedure to be saved in the dlog for analysis therefore image analysis could not be completed for this procedure.Review of the run data file showed the system to be operating as intended with the proper alarms raised.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 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 hemolysis (cherry red) occurred in the connector and cassette and a "cells detected in the plasma line in centrifuge" alarm 3 minutes into a therapeutic plasma exchange (tpe) procedure.The customer stated that the patient had hemodialysis (hd) prior to the procedure and that this was the patient's 2nd procedure.There were no issues with the first procedure.The customer stated that the patient had chemotherapy the saturday before the procedure.The replacement fluid was mixed by rx - 5% albumin mixed with mg sulfate 7.5 meq, cagluconate 16.8 meq, kcl 15 meq and nothing else.The physician decided to have the replacement fluid tested and a post complete blood count, lactate dehydrogenase, comprehensive metabolic panel, biliribuin, and albumin levels.The patient is in stable condition.The collection set is not available for return because it was discarded by the customer.

• 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: 18495208
• MDR Text Key: 333099297
• Report Number: 1722028-2024-00015
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4122201
• Device Lot Number: 2307216141
• 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
• Date Device Manufactured: 07/21/2023
• 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 Age: 66 YR
• Patient Sex: Female