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

Catalog Number 80440

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the device history records (dhr) were reviewed for this event.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The run data file (rdf) was analyzed for this event.Root cause: a definitive root cause for the observed leuko reduction failure remains undetermined at this time.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.It also cannot be ruled out that a sampling, calculation, or other process error could have contributed to the higher-than-expected wbc content in the platelet product.

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 bloodcell (rwbc) testing, therefore, no patient information is reasonably known at the time of the event.(b)(6).The disposable kit is not available for return, because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10810 w collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 5164189
• MDR Text Key: 29217990
• Report Number: 1722028-2015-00593
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/28/2015

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: 08/01/2017
• Device Catalogue Number: 80440
• Device Lot Number: 08Y1120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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