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

Catalog Number 000000000000080400

Device Problem Low Test Results (2458)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

The customer would like the run data file investigated to determine a possible cause for the higher-than-expected 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 # (b)(6) the disposable set was unavailable for return, because the customer discarded it.This report is being filed due to device malfunction, that has the potential for injury.

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 leukoreduction failure remains undetermined at this time.Signals in the data file shows each of the access pressure alerts that occurred during this run caused the pumps to pause which can affect the steady state of the system.While the trima accel system is typically robust against numerous flow alerts and adjustments, it is likely that the high number of alerts that occurred during the procedure could have disrupted the steady state of the system and contributed to the higher-than-expected wbc content in the platelet product.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; 10811 w collins avenue; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10811 w collins avenue; lakewood, CO 80215 ; 3032052282
• MDR Report Key: 3741504
• MDR Text Key: 17615706
• Report Number: 1722028-2014-00115
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120049
• 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: 03/14/2014

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: 02/01/2016
• Device Catalogue Number: 000000000000080400
• Device Lot Number: 02W3306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2014
• 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