MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLATELET PLASM RBC AUTOPAS SET

Model Number 80410

Device Problems Contamination of Device Ingredient or Reagent (2901); No Apparent Adverse Event (3189)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

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.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Wbc count is not available at this time.The disposables set is not available for return because it was discarded by the customer.

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.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: two photographs were submitted by the customer to aid the investigation.The photographs show a used trima accel cassette and platelet bags.A rbc spillover is evident in the platelet collect line and platelet bags - the platelets in the collect bag have a pink/red color.The platelet channel line clamp has been assembled onto the correct line and appears to be adequately occluding the platelet tubing.No damage to or molding defects on the clamp are visible.The run data file was analyzed for this event.The analysis of the run data file during the pas addition showed rbcs consistently passed the rbc detector from the beginning of the process.This can happen if one or more of the 3 channel clamps are left open or if partial occluded during the pas addition phase.If these clamps are not fully occluding the channel line, fluid from the channel containing rbcs and wbcs is pulled up and can enter the product bags, causing the product to turn pink or red.During the pas addition phase, the device monitors the correct closing of the channel line clamps.A ¿channel line clamp error¿ is generated when the device cannot verify that the channel lines are completely occluded.The verification during the addition phase is based on a change of the rbc detector reading.If the reading increases too much beyond the baseline, then a ¿channel line clamp error¿ alert is generated.The procedure is flagged for potential wbc contamination.Upon connection of the second pas bag, the device has not detected pas, therefore a ¿pas prime error¿ alert was generated.It is possible though not conclusive, the ¿pas prime error¿ alert may have been caused by: pas bag not connected correctly; pas bag frangible not broken correctly; pas line clamp not opened completely no further reporting will be provided as this does not represent a reportable event.It was confirmed that this was flagged for potential wbc contamination due to channel line clamps not closed during pas addition.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLATELET PLASM RBC AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80214
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80214
• MDR Report Key: 13048348
• MDR Text Key: 287273764
• Report Number: 1722028-2021-00391
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804104
• UDI-Public: 05020583804104
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 12/20/2021

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: 09/01/2022
• Device Model Number: 80410
• Device Catalogue Number: 80410
• Device Lot Number: 2009031130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2020
• 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