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

Model Number 80400

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

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 #: w04702003353700f the platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provided additional information in b.6 and h.10.Investigation: 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.It was confirmed that the trima machine flagged the contamination for this event.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: the taps report was reviewed and revealed the procedure was flagged by trima to verify wbcs in platelet product.The device history record was reviewed for this lot.There were no issues noted that would have contributed to this event.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: ¿ rbc spill over ¿ centrifuge stopped ¿ rbc detector calibration error ¿ possible air block ¿ the orientation of the tubing as loaded in the centrifuge hex holder and the compromised structural integrity of the plasma tubing.Effectively, there is a certain orientation in the hex holder that allows for the rbc line to lie on top of the plasma line and, under certain flow conditions, may cause the plasma line to pinch off.This in turn causes higher flow through the lrs chamber, which may lead to elevated levels of wbcs in the platelet product.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9768759
• MDR Text Key: 185295401
• Report Number: 1722028-2020-00083
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 80400
• Device Catalogue Number: 80400
• Device Lot Number: 1812074151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other