MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER PLASMA RBC SET

Model Number 80440

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content in the platelet product reported for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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 #: w035420018871 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 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

This report is being filed to provide corrected information in b.5 and b.6 investigation is in process.A follow-up report will be provided.

Event Description

Corrected donor unit #: (b)(4).

Manufacturer Narrative

Root cause: the analysis of the run data file did not find a conclusive cause for the higher-than- expected wbc content in the platelet product reported for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Based on the available information, it cannot be ruled out that the higher- than- expected wbc content in the platelet product could be donor-related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9943431
• MDR Text Key: 188113230
• Report Number: 1722028-2020-00154
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 80440
• Device Catalogue Number: 80440
• Device Lot Number: 1910315251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other