MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA SET

Model Number	80400
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem 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.No patient (donor) was connected at the time of the event, therefore, no patient information is known.Wbc count is unknown at this time.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis showed that the platelet product could not be labeled as leukoreduced and verification messages were shown at the end of run summary screens for the following reasons: rbc spillover detected and platelet contamination detected.Review of the run data file showed that platelets were not exiting the lrs chamber as expected and that the steady state of the lrs chamber was interrupted.It is possible, though not conclusive, an air block, plasma line occlusion, kinked or occluded platelet bag line, loading error, or tubing set manufacturing defect may have contributed to the interruption of the steady state of the lrs chamber.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.During customer follow-up, it was confirmed that the device flagged based on the rdf analysis provided.No further reporting will be provided as this does not represent a reportable event.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC PLT/PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 12093268
• Report Number: 1722028-2021-00226
• Device Sequence Number: 1521515
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: 80400
• Device Catalogue Number: 80400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other