MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; ACCEL PLT,PLASMA,ISBT

Model Number 80300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

The customer submitted three photographs in lieu of the disposable set to aid investigation.One image shows a platelet bag and a plasma bag hung on the iv pole.The primary platelet bag was approximately a third full and the product is noted to be red.There was a small amount of plasma collected and the contents appeared to be clear.The second image shows the set loaded in the centrifuge.The channel and connector are noted to be fitted optimally in the filler.The lower hex appears to be loaded at the correct orientation, the lrs chamber is loaded correctly, and none of the lines are overlapping.There appeared to be a large platelet aggregate in the inlet channel line.The third image shows the cassette loaded on a trima device and all pump header tubing appears to be loaded in their raceways correctly.The rbc detector is noted to be flashing green.The platelet lines through the cassette are observed to be pink tinged in color.The plasma line is yellow.The platelet and plasma valves are closed, and the rbc valve is open.A disposable complaint history search was performed for this lot and found another report for similar issues on this lot.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the hemolysis experienced by the customer.The run data file was analyzed for the event.Run data file analysis showed signals from the rbc detector appeared as expected until about 13 minutes into the procedure.Collection of the plasma volume for plasma rinseback had already completed and the pumps had finished ramping to their target collection flow rates.Beginning around 13 minutes into the procedure and continuing throughout the remainder of the collection, the rbc detector reading began steadily increasing.Although steadily increasing, the readings never reached the detection level for an ¿rbc spillover¿ alert.The rbc detector readings also showed very little and decreasing platelet concentration passing the rbc detector, indicating very few platelets were being collected into the platelet product bag.The operator was notified of this at the ¿low platelet concentration detected¿ alert.It is possible, though not conclusive, this alert was generated due to platelet clumping forming within the tubing set, including the channel.This may occur when the incorrect solution was attached to the ac line, the ac line was partially occluded, or the ac was not connected properly.It is also possible, though not conclusive, a donor related phenomenon increased this donor¿s potential for platelets to clump throughout the procedure.When the ¿low platelet concentration detected¿ alert called the operator to the device, the operator likely noticed the red coloring in the platelet product bag and initiated an rbc spillover recovery process.This recovery process did not return the rbc detector reading to expected signals.Since the rbc spillover recovery process did not appear to resolve the issue, it is possible, though not conclusive, the too red platelet product may have been due to potential hemolysis that formed within the tubing set.It is suspected clumping within the tubing set contributed to the potential hemolysis in this procedure.A few minutes after the rbc spillover recovery process, a ¿centrifuge pressure high¿ alert was generated.The operator continued from this alert, however a few minutes later a second ¿centrifuge pressure high¿ alert was generated.Analysis suspects platelet clumps that had formed within the cassette inlet line had broken off and entered the inlet centrifuge line.These clumps blocked the flow into the channel, causing the centrifuge pressure to increase.The second ¿centrifuge pressure high¿ alert was generated at the start of the return cycle.At a ¿centrifuge pressure high¿ alert, the centrifuge is stopped, which causes fluid to be expressed from the channel into the reservoir.Therefore, the reservoir likely filled into the vent bag following this alert.When the operator continued from this alert, a ¿level sensor error¿ alert was generated due to a long return cycle.It is suspected the excess volume in the reservoir from the centrifuge stop at the ¿centrifuge pressure high¿ alert contributed to this alert.The draw cycle following the long return cycle was shown to have a second ¿level sensor error¿ alert.This alert was generated due to a long draw cycle.It is possible, though not conclusive, the upper level reservoir sensor missed detection of fluid due to foaming in the reservoir that formed at the previous alerts and fluid entering the vent bag in the prior cycle.Root cause: a root cause assessment was performed for this complaint.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: * donor susceptibility causing low level hemolysis in the platelet and plasma products.* high shear rates on a platelet (white stamp) disposable set resulting in hemolyzed blood back to donor due to one of the following causes: inappropriate needle gauge (sterile doc at customer or misassembly in manufacturing); occlusion or kinks in lines; return line occlusion; high hematocrit in needle, rbc line; loop vibration; centrifuge imbalance; needle flow rate too high; manufacturing defects (flashing, excess header lengths); failures in the control system cause high hematocrit in the reservoir.* rbc line occlusion causes backpressure in rbc line forcing blood to take alternate route to reservoir resulting in blood damage.

Event Description

An investigation was conducted for reports of hemolysis in the plasma product.The customer reported the collected platelet was red during the run.The operator checked the tubing line and found rbcs in plasma line and platelet line.The operator adjusted parameters, and then the machine alarmed 'centrifuge pressure high' and 'level sensor error'.Medical intervention was not necessary for the patient (donor).The donor was reported as stable.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: ACCEL PLT,PLASMA,ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80218
• 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: 15149991
• MDR Text Key: 304818078
• Report Number: 1722028-2022-00250
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK190332
• 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
• Report Date: 08/02/2022

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: 01/02/2024
• Device Model Number: 80300
• Device Catalogue Number: 5803001
• Device Lot Number: 2201035151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2022
• Initial Date FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2022
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 85 KG