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

Model Number 80400

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 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry date are not available at this time.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 elevated white blood cell (wbc) content in the plasma product.No alarms displayed during the procedure.Customer reported that there was blood in the plasma bag.The donor blood was very lipemic and the procedure was stopped by the customer due to rbc spillover.Wbc count is not available at this time.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 platelet collection 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 elevated white blood cell (wbc) content in the plasma product.No alarms displayed during the procedure.Customer reported that there was blood in the plasma bag.The donor blood was very lipemic and the procedure was stopped by the customer due to rbc spillover.Wbc count is not available at this time.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 platelet 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, h.6 and h.10.Lot number, manufacture date and expiry date are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not show a conclusive root cause for the red blood cells found in the plasma bag.There were no events (alerts, adjustments, changes in pump speed, substate changes, etc.During the procedure that could have caused rbcs to enter the plasma bag.It is possible, though not conclusive, the red blood in the plasma bag may have been caused by: - entered donor hematocrit lower than the actual donor hematocrit - loading error of the tubing set, such as misloaded plasma pump header tubing - potential donor related failure, such as low rbc mcv - potential disposable set defect it is possible the interface gets out of control when the plasma and/or platelet line are pulling off too much fluid.The reported spillover in the plasma line remained undetected as the platelet line has the lrs chamber to hold the rbcs within.The customer submitted two photographs in lieu of the disposable set to aid investigation.The images show the disposable cassette loaded correctly on the trima device.The run screen shows draw in progress.Blood is observed in the left-hand side of the cassette.The plasma and platelet lines are noted to be pale yellow in color.The plasma bag in approx.One third full and the color of the plasma product is noted to be dark yellow/red.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.4, h.6 and h.10.Corrected information is provided in d.4.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not show a conclusive root cause for the red blood cells found in the plasma bag.There were no events (alerts, adjustments, changes in pump speed, substate changes, etc.During the procedure that could have caused rbcs to enter the plasma bag.It is possible, though not conclusive, the red blood in the plasma bag may have been caused by: - entered donor hematocrit lower than the actual donor hematocrit - loading error of the tubing set, such as misloaded plasma pump header tubing - potential donor related failure, such as low rbc mcv - potential disposable set defect it is possible the interface gets out of control when the plasma and/or platelet line are pulling off too much fluid.The reported spillover in the plasma line remained undetected as the platelet line has the lrs chamber to hold the rbcs within.The customer submitted two photographs in lieu of the disposable set to aid investigation.The images show the disposable cassette loaded correctly on the trima device.The run screen shows draw in progress.Blood is observed in the left-hand side of the cassette.The plasma and platelet lines are noted to be pale yellow in color.The plasma bag in approx.One third full and the color of the plasma product is noted to be dark yellow/red.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that there was no allegation of wbc failure for this event.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the plasma product.No alarms displayed during the procedure.Customer reported that there was blood in the plasma bag.The donor blood was very lipemic and the procedure was stopped by the customer due to rbc spillover.Wbc count is not available at this time.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 platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC 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: 13861345
• MDR Text Key: 297321622
• Report Number: 1722028-2022-00091
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 80400
• Device Catalogue Number: 82420
• Device Lot Number: 2104051130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2021
• 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