MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS, PLASMA,

Catalog Number 82420

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

Patient Problems Dizziness (2194); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable history search confirmed there were no occurrences of a similar issue reported on this lot worldwide.The run data file (rdf) was analyzed for this event.The run data file showed the operator paused the procedure at 4 minutes into the run, after 95ml of donor blood volume had been processed.This pause button press occurred about 20 seconds into the first return cycle.The lower level reservoir sensor was shown to consistently detect fluid after the return line was primed.There is no evidence or suspicion of device malfunction based on the run data file analysis.According to aabb technical manual 16th edition, adverse events 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 3400 donors.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that for a collection procedure, once the procedure had begun and 90 cc of whole blood had been extracted, the donor felt dizzy, diaphoresis and lost consciousness.A pain stimulus was applied to the donor and the dizziness continued.The donor was administered saline solution and was transferred to the emergency department where crystalloids were administered and an electrocardiogram was performed.The donor was discharged after complete recovery.The disposable set is not available for return because it was discarded by 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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: a definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS, PLASMA,
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11454029
• MDR Text Key: 242382989
• Report Number: 1722028-2021-00104
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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: 08/01/2022
• Device Catalogue Number: 82420
• Device Lot Number: 2008311230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACD LOT: 20063034EXPIRATION DATE: 05-22-01
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00039 YR
• Patient Weight: 69