MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET

Catalog Number 82321

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

Patient Problems Stroke/CVA (1770); Dizziness (2194)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: customer did not allege that the machine or procedure caused or contributed to the patient¿s event.The customer did not provide the lot number pertaining to this event, therefore, a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The run data file (rdf) was analyzed for this event.Review of the run data file confirmed that there was no system or device malfunction identified that would indicate an issue with the trima system or that the system contributed to the donor reaction.The system was operating within manufacturer's specifications.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 a patient underwent a platelet collection procedure on trima on (b)(6) 2019 without any issues.On the following day approximately 24 hrs post procedure, the patient experienced dizziness and light headedness and the patient was admitted to the hospital for further investigation.Per the customer, the patient felt unwell and experienced a stroke.No medical intervention was performed at the time of the donation as the donor was well on the day of and the donation was completed without any event.The platelet collection set is not available for return because it was discarded by the customer.Due to eu personal data protection laws, patient outcome is not available from the customer.Donor gender and weight were obtained from the run data files.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 in investigation: there was no system or device malfunction identified that would indicate anissue with the trima system that would have contributed to the donor's stroke.The systemoperated as intended and within the safety limits programmed in the machine.Review of the run data file(rdf) showed that the platelet valve opened at 12 minutes and theplatelets exited as expected.The total amount of ac reported by the trima accel device was 375ml with 286 mls to the donor, 75 mls in the platelet product and the remaining 14 mls in thekit.There were no events (alerts, adjustments, changes in pump speed, etc.) during the courseof the run that could have caused the reported donor reaction.Corrected investigation: a review of the device history record (dhr) for this unit showedno irregularities during manufacturing that were relevant to this issue.Root cause: the dlog confirmed that return cycle monitoring, ac occlusion monitoring, ac fluiddetector monitoring and low level sensor monitoring performed as intended.Rdf analysisconfirmed that redundant air to donor safety protection performed as intended.In addition, thecustomer did not allege leak in the disposable set that could have pulled air into the return lineunder negative pressure or return of clots to the donor.As evidenced by the dlogs, customer statement, and the dhr, the device did not cause orcontribute to the donor's stroke.The system operated as intended and the device was foundsafe to use.A definitive root cause for the donor's stroke could not be determined.Possible causes includebut are not limited to donor's underlying disease/physiology.

Event Description

After multiple attempts from terumo bct to obtain patient information, the customer declinedto provide any due to eu personal data protection laws.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8322961
• MDR Text Key: 135707092
• Report Number: 1722028-2019-00032
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 02/08/2019

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: 09/01/2020
• Device Catalogue Number: 82321
• Device Lot Number: 1809252130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00059 YR
• Patient Weight: 116