MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET AUTO PAS, PLASMA, RBC SET

Model Number 82410

Device Problems Contamination (1120); Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, as shown in photos provided, the white clamps are correctly closed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.Per the customer, when the pas solution was sent to the platelet product, the blood that was in the lines contaminated the platelet concentrate, for which they had to use surgical forceps to stop the contamination.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.The wbc count is not available, at this time.

Manufacturer Narrative

Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The customer submitted four photographs in lieu of the disposable set to aid investigation.Three images show the cassette loaded onto the trima device and blood is observed in the inlet line, draw/return pressure sensor, inlet line trap, return line, rbc line from centrifuge, platelet line from centrifuge and platelet recirc line, plasma line from centrifuge up to the white mini pinch clamp and in the reservoir.Foam/air bubbles are also observed in the reservoir.The mini pinch clamps are assembled on the correct lines and appear in the closed position.The forth image shows blood in the platelet bag.Investigation is in process.A follow up report will be provided.

Event Description

After multiple follow-up attempts, wbc count and further procedural details were not provided for this event.

Manufacturer Narrative

Investigation: four procedures were carried out on 3 separate donors on trima device 1t01466r on (b)(6) 2020.A dlog analysis could not be performed as terumo bct was unable to identify the specific procedure.Attempts to confirm the procedure with the customer were unsuccessful.A review of the procedures via taps report indicated that one of the four procedures flagged with the message ¿verify the wbc content in the platelet product¿.Root cause: a definitive root cause could not be determined.Possible causes for rbcs entering the platelet product bag during pas addition include, but are not limited to: ¿ ineffective cassette cleaning during the pas priming process where the system cannot identify a change in the signal to detect passing rbcs ¿ platelet and/or plasma channel line clamps may not have been fully occluding the channel lines, allowing fluid from the channel containing rbcs to be pulled up into the platelet product bags ¿ inadequate pas fluid connection, causing any rbc contents within the cassette to enter the platelet product bags ¿ incorrectly primed filter on the pas line ¿ pas bag frangible not broken correctly or reseated ¿ yellow clamp on the pas line not opened fully.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET AUTO PAS, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10885733
• MDR Text Key: 220980390
• Report Number: 1722028-2020-00519
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2020

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: 05/01/2022
• Device Model Number: 82410
• Device Catalogue Number: 82410
• Device Lot Number: 2005042130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 02/24/2021; 07/01/2021
• Supplement Dates FDA Received: 03/17/2021; 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other