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

Model Number 82666

Device Problems Obstruction of Flow (2423); High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was due to plasma line occlusion.The centrifuge stop during blood prime due to 'centrifuge pressure too high' alert may have introduced an airblock in the plasma centrifuge line.Plasma line occlusion results in more volume being drawn through the lrs chamber than intended, which disrupts leukoreduction.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 elevated white blood cell (wbc) content in the platelet product.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.Donor unit #: (b)(6).The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additiona information in h.6 and h.10 investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause : the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was due to plasma line occlusion.The centrifuge stop during blood prime due to 'centrifuge pressure too high' alert may have introduced an airblock in the plasma centrifuge line.Plasma line occlusion results in more volume being drawn through the lrs chamber than intended, which disrupts leukoreduction.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER, PLASMA, AUTO RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11223172
• MDR Text Key: 238895343
• Report Number: 1722028-2021-00025
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583826663
• UDI-Public: 05020583826663
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 82666
• Device Catalogue Number: 82666
• Device Lot Number: 2012032130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other