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

Model Number 82410

Device Problems Output Problem (3005); No Apparent Adverse Event (3189)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned a used trima set for investigation.Visual inspection confirmed the set appeared to be assembled properly with no obvious manufacturing defects.There were no leaks, missing parts or misassemblies identified.The presence of blood was confirmed throughout the disposable set.There was no evidence of clotting within the tubing set.The kit was flow tested successively, however liquid would not flow through the pas filter.The pas line was dismantled and a sharp tool was pushed down inside the filter inlet bond port.Liquid was then able to pass thorough the filter.A witness line on the lower hex confirmed the kit was loaded into the centrifuge properly.The run data file (rdf) was analyzed for this event.Review of the run data file confirmed that the rbc signal during the platelet additive solution addition phase is conform a blocked pas line, indicating an insufficient flow of liquid through the pas line.A ¿platelet additive solution prime error¿ alert was displayed to inform the operator about insufficient pas flow.Based on the available information the inlet port of the pas filter was blocked.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that when the donation was finished, they were not able to add the pas, even after repeated attempts and despite "everything being open".There was not a transfusion recipient or patient involved at the time of the pas addition, therefore no patient information is reasonably known at the time of the event.Wbc count is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.During customer follow-up, it was confirmed that the rbcs in the tubing kit were due to rinseback.No further reporting will be provided as this does not represent a reportable event.The customer returned a used trima set for investigation.Visual inspection confirmed the set appeared to be assembled properly with no obvious manufacturing defects.There were no leaks, missing parts or misassemblies identified.The presence of blood was confirmed throughout the disposable set.There was no evidence of clotting within the tubing set.The kit was flow tested successively, however liquid would not flow through the pas filter.The pas line was dismantled and a sharp tool was pushed down inside the filter inlet bond port.Liquid was then able to pass thorough the filter.A witness line on the lower hex confirmed the kit was loaded into the centrifuge properly.The run data file (rdf) was analyzed for this event.Review of the run data file confirmed that the rbc signal during the platelet additive solution addition phase is conform a blocked pas line, indicating an insufficient flow of liquid through the pas line.A ¿platelet additive solution prime error¿ alert was displayed to inform the operator about insufficient pas flow.Based on the available information the inlet port of the pas filter was blocked.The customer returned a used trima kit for investigation.Visual inspection confirmed the set appeared to be assembled properly with no obvious manufacturing defects.There were no leaks, missing parts or misassemblies identified.The presence of blood was confirmed throughout the disposable set.There was no evidence of clotting within the tubing set.The kit was flow tested successively, however liquid would not flow through the pas filter.The pas line was dismantled and a sharp tool was pushed down inside the filter inlet bond port.Liquid was then able to pass thorough the filter.A witness line on the lower hex confirmed the kit was loaded into the centrifuge properly.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a failure to remove excess solvent when bonding tubing to the pas filter during manufacturing.

Event Description

The customer reported that when the donation was finished, they were not able to add the pas, even after repeated attempts and despite "everything being open".There was not a transfusion recipient or patient involved at the time of the pas addition, therefore no patient information is reasonably known at the time of the event.Wbc count is not available.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL: LRS PLATELET, PLASMA, RBC + AUTO
• 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: 14574735
• MDR Text Key: 301290374
• Report Number: 1722028-2022-00172
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: BK190332
• 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
• Report Date: 06/02/2022

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: 82410
• Device Catalogue Number: 5824102
• Device Lot Number: 2201094151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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