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

Catalog Number 80350

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the disposable was not available for return for evaluation.The run data file(rdf) was analyzed for this event.Root cause: a definitive root cause for the observed leukoreduction failure remainsundetermined at this time.The analysis of the procedural data file did not find a conclusivecause for the higher-than-expected wbc content in the platelet product reported for thiscollection.No unusual process variable was identified and the signals in the run data file indicatethat the trima accel system operated as intended.Based on the available information, it cannotbe ruled out that the higher-than-expected wbc content in the platelet product could bedonor-related.It also cannot be ruled out that a sampling, calculation, or other process errorcould 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 theelevated 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 theevent.D nor unit #: (b)(4).The disposable kit is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC, AUTO RAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5320691
• MDR Text Key: 34931447
• Report Number: 1722028-2015-00693
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150269
• 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: 12/22/2015

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: 10/01/2017
• Device Catalogue Number: 80350
• Device Lot Number: 10Y3106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2015
• 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