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

Catalog Number 80420

Device Problems Excess Flow or Over-Infusion (1311); Misassembled (1398); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The channel clamp closure test was completed successfully.The rinsing of the cassette with platelet additive solution and the addition of the pas volume was performed as expected.It is possible that an external clamp was placed on the platelet channel line, prior to start the channel clamp closure test.Investigation is in process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.The platelet collection 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.Wbc count is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: a photograph was submitted in lieu of the disposable to aid in the investigation.The photo confirms the white mini pinch clamp is missing from the platelet line exiting the centrifuge.Root cause: the channel clamp closure test was completed successfully.The rinsing of the cassette with platelet additive solution and the addition of the pas volume was performed as expected.It is possible that an external clamp was placed on the platelet channel line, prior to start the channel clamp closure test.Correction: retraining of the manufacturing staff was conducted.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET,SAMPLER,AUTO PAS,PLASMA,RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10134113
• MDR Text Key: 200865277
• Report Number: 1722028-2020-00284
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 80420
• Device Lot Number: 2001102130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2020
• 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