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

Catalog Number 12220

Device Problem Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The customer reported that during the beginning of a red blood cell exchange (rbcx) procedure they received a "cells detected in plasma line" alarm and observed hemolysis in the plasma line in the centrifuge.The procedure was stopped.No clots were observed in the channel or channel lines.Patient information and outcome are unknown at this time.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

Lot number, manufacture and expiry date are not available at this time.Investigation: per the customer, the solutions were 0.9% normal saline, anticoagulant citrate dextrose solution a(acd-a) and red blood cells (rbc) and they were correctly attached.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

And h.10.Investigation: per the customer, the solutions were 0.9% normal saline, anticoagulant citrate dextrose solution a(acd-a) and red blood cells (rbc) and they were correctly attached.Per additional follow up from the customer, the patient reported no complaints and had no fever, back pain, headache, dizziness, chest pain, or sob.Vitals were within normal limit.The procedure was stopped.Post-transfusion ua was negative for hemoglobinuria.Work-up for hemolysis and dat were negative for patient blood sample.Samples from apheresis ring and the rbc unit was 2-3+ hemolysis visually and sample from waste bag was negative for hemolysis visually.Therefore, the hemolysis seems to be within the instrument, and not in the patient.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during the beginning of a red blood cell exchange (rbcx) procedure they received a "cells detected in plasma line" alarm and observed hemolysis in the plasma line in the centrifuge.The procedure was stopped.No clots were observed in the channel or channel lines.Patient was reported as discharged home.Terumo bct is awaiting return of the disposable set for evaluation.

Event Description

The customer reported that during the beginning of a red blood cell exchange (rbcx) procedure they received a "cells detected in plasma line" alarm and observed hemolysis in the plasma line in the centrifuge.The procedure was stopped.No clots were observed in the channel or channel lines.Patient was reported as discharged home wit no issues and vitals were within normal limit.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, the solutions were 0.9% normal saline, anticoagulant citrate dextrose solution a(acd-a) and red blood cells (rbc) and they were correctly attached.The unit expiration date was 02/04/2024.Per additional follow up from the customer, the patient reported no complaints and had no fever, back pain, headache, dizziness, chest pain, or sob.Vitals were within normal limit.The procedure was stopped.Post-transfusion ua was negative for hemoglobinuria.Work-up for hemolysis and dat were negative for patient blood sample.Samples from apheresis ring and the rbc unit was 2-3+ hemolysis visually and sample from waste bag was negative for hemolysis visually.Therefore, the hemolysis seems to be within the instrument, and not in the patient.Four photographs were provided to tbct clinical support which confirmed the plasma in the cassette and connector was red tinged.No obvious misassemblies, kinks, or occlusions can be observed in the photographs provided.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.The run data file (rdf) was analyzed for this event.Review of the relevant rdf does not indicate a conclusive root cause for the 9 occurrences of the alarm ¿cells were detected in plasma line from centrifuge¿.The first occurrence of this alarm happened at roughly 8 minutes into the procedure and occurred a total of 7 times.In rbcx procedures, the system generates this alarm when the rbc detector signals are greater than 1.5.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hct was too low causing cells to exit through the plasma line, a shift in fluid balance that caused the actual patient hct to increase as the procedure progressed, or hemolysis may have occurred.To respond to this alarm, the operator should look through the view port to see the position of the rbc interface.If the interface is too high or there are swirls of platelets in the plasma it is recommended to increase the patient hct by 3 percentage points.If the alarm recurs, increase the hematocrit by 3 percentage points again.The operator may increase the hct this way up to three times for a maximum increase of 9 percentage points.The input patient hct directly controls the pump flow rates which control the position of the interface.In this procedure the operator correctly responded to the alarm by increasing the originally input patient hematocrit by 3% two separate times.Review of the aim images show the cell interface had risen to the middle of the channel connector by roughly 8 min into the procedure.Aim images show the interface dropped low shortly after before raising to the middle of the channel once more and remaining at this height for the rest of the procedure.During rbcx, the cell interface should remain near to bottom of the channel connector throughout the procedure.A higher cell interface in the channel connector indicates cells were building up in the centrifuge.A high cell interface may cause cells to exit through the plasma line and trigger the observed alarm.In rbcx, the aim system monitors the intensity of the light near the top and bottom of the connector to detect any rbc spillover; however, it does not monitor or control the interface position during an rbcx procedure.Since the cell interface did not rise to the top of the channel connector, no interface alarm was raised.The operator did correctly increase the patient hematocrit in response to this alarm occurrence.Increasing the patient hct may have helped avoid the observed alarm by lowering the cell interface.The dlog showed rbc detector signals quickly rose at roughly 7 minutes into the procedure to a maximum of roughly 2.75.Since the signals reached a value higher than 1.5 the ¿cells were detected in plasma line from centrifuge¿ alarm was raised.The rbc detector signals dropped below 1.5 at roughly 15 minutes, just underneath 1.3, before once again rising slightly above 1.5 by the end of the procedure.A higher rbc detector signal generally signifies a darker color at the plasma line which in turn may indicate a greater cell presence.However, this detector signal cannot indicate what kind of cells are present in the plasma line and cannot confirm the occurrence of hemolysis.If hemolysis is suspected, it is important to consider if the patient condition may cause it and perform hemolysis testing to confirm.In this report the customer reported hemolysis testing was performed on patient and was negative.From dlog analysis it cannot be confirmed that the occurrence of red tinged plasma was hemolysis.In this procedure, a higher cell interface towards the end is an indication that cells may have been the cause of the observed alarm.Investigation is in process, a follow-up report will be provided.

• 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: 18623316
• MDR Text Key: 334328075
• Report Number: 1722028-2024-00035
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Device Lot Number: 2309273141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• 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: 17 YR
• Patient Sex: Female
• Patient Weight: 60 KG