MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUT

Catalog Number 82383

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nausea (1970)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Investigation: one used trima set was received for investigation.Initial observations noted the 1000ml macopharma ac bag was returned and contained approximately 800ml of solution.Visual inspection noted blood throughout the set with clumping in the inlet filter trap, the reservoir, the cps, the connector, and the return pump header tubing.Further inspection of the set observed the mini pinch clamps were in the closed position but one of them was assembled on the wrong line; a clamp was assembled on the inlet line instead of the rbc line.The additive solution line was unused, and the yellow pinch clamp was in the closed position.Witness marks on the bearings and lower hex indicate that the loop was loaded optimally.The set was further inspected for any other misassemblies or kinks or missing parts and none were found.The reported adverse events are common side effects of apheresis donations.According to aabb technical manual 16th edition, adverse reactions seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 34 donors.Vasovagal reaction complex includes dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.In severe cases, syncope and convulsions may be observed.The pulse rate is often low during vasovagal reactions while the rate is often high during volume depletion.Some donors with severe reactions or those with prolonged recovery times may need short-term observation, intravenous fluid administration in the emergency room, or both.A disposable lot history search indicated there were no other reported occurrences of adverse reactions on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a specific root cause for the reported reaction could not be determined.The reported adverse reactions are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, donor's sensitivity to the procedure and/or hemodynamic stress of the procedure.The procedure was interrupted because of the donor's reaction.The customer did not achieve the target yield as a result.

Event Description

The customer stated that the donor felt nauseated so the target yield was lower than expected at the end of the donation.The customer declined to share any medical information pertaining to the donor.It is unclear if medical intervention was required for this event.Due to eu personal data protection laws, the patient information is not available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLT W/FILTER+SAMPLER+AUT
• 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: 14645587
• MDR Text Key: 294809069
• Report Number: 1722028-2022-00195
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/09/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 82383
• Device Lot Number: 2108132130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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