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

Model Number 80300

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dizziness (2194); Cough (4457)

Event Date 08/14/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: a photograph was submitted in lieu of the disposables set to aid in the investigation.The picture confirm that the blood diversion bag was inflated with pressurized air.The clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass during pressure test.The run data file (rdf) was analyzed for this event.The ¿pressure test error¿ alert generated during the tubing set test in this procedure occurred because the expected pressure increase was not seen in the allotted volume pumped.Analysis of the run data file suspects that the pressure increase was not sufficient because the pinch clamp on the sample bag line was likely not occluding the line properly.If the clamp on the sample bag line is not occluding the line properly during the tubing set test, air can have a pathway to enter the sample bag.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the air to donor by the customer.Correction: the local support team retrained the operator on (b)(6)2022.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported an incident of air in the blood diversion bag during setup/post tubing set test.The operator did not notice the air in the bag and connected the donor and opened the sample bag clamp.The operator heard "a sound of gas" and noticed that the sample bag was inflated.The operator closed the clamp and removed the air in sample bag, then continued the procedure.During the collection process, the donor felt chest distress, dizzy and cough, and the draw pressure was low.The operator had to end the procedure.The donor returned to normal after rest.The customer declined to provide the donor's id or age.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer reported an incident of air in the blood diversion bag during setup/post tubing set test.The operator did not notice the air in the bag and connected the donor and opened the sample bag clamp.The operator heard "a sound of gas" and noticed that the sample bag was inflated.The operator closed the clamp and removed the air in sample bag, then continued the procedure.During the collection process, the donor felt chest distress, dizzy and cough, and the draw pressure was low.The operator had to end the procedure.The donor returned to normal after rest.The customer declined to provide the donor's id or age.The disposable 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 h.6 and h.10.Corrected information is provided in b.3.Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content in the platelet product reported for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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.Root cause: based on the available information, the analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content in the platelet product reported for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA 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: 15379674
• MDR Text Key: 305616410
• Report Number: 1722028-2022-00298
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 80300
• Device Catalogue Number: 5803001
• Device Lot Number: 2203154151
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2022
• 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
• Patient Sex: Male
• Patient Weight: 63 KG