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

Model Number 82410

Device Problems Display or Visual Feedback Problem (1184); 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  

Event Description

The customer reported that at the end of the donation procedure, just before the final signal alarm, they received a level sensor error - plasma not draining for plasma rinseback alarm and had to stop the procedure.When the pas was added, they received the alarm channel volume too high - inlet volume too high.They completed the procedure, then added the pas in the lab.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.

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, defects or occlusions identified.The presence of blood was identified throughout the set.The kit was flow tested successively including the pas line with no restrictions identified.In summary, no disposable defects were identified.The run data file (rdf) was analyzed for this event.The procedure was ended successfully with partial rinseback at 36 minutes.During the plasma rinseback substate a ¿level sensor error¿ alert (alert 187) was presented.The alert screen was cleared, the donor was disconnected and the device transited to the platelet additive solution addition phase.During the platelet additive solution addition phase, a ¿channel volume too high¿ non-recoverable alarm (alarm 71) was presented.Ending the platelet additive solution addition was the only option.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.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, defects or occlusions identified.The presence of blood was identified throughout the set.The kit was flow tested successively including the pas line with no restrictions identified.In summary, no disposable defects were identified.The run data file (rdf) was analyzed for this event.The procedure was ended successfully with partial rinseback at 36 minutes.During the plasma rinseback substate a ¿level sensor error¿ alert (alert 187) was presented.The alert screen was cleared, the donor was disconnected and the device transited to the platelet additive solution addition phase.During the platelet additive solution addition phase, a ¿channel volume too high¿ non-recoverable alarm (alarm 71) was presented.Ending the platelet additive solution addition was the only option.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 pas addition for this event, therefore, no potential for rwbc contamination.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported that at the end of the donation procedure, just before the final signal alarm, they received a level sensor error - plasma not draining for plasma rinseback alarm and had to stop the procedure.When the pas was added, they received the alarm channel volume too high - inlet volume too high.They completed the procedure, then added the pas in the lab.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.

• 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: 14575634
• MDR Text Key: 301034953
• Report Number: 1722028-2022-00174
• 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: 01/01/2024
• 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: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2022
• 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