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

Catalog Number 000000000000080400

Device Problem High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2014

Event Type  malfunction  

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 wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6) the disposable set is unavailable for return because the customer discarded it.This report is being filed due to a device malfunction that has the potential for injury.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and investigation.He run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher than expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber during a portion of the procedure.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.

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.Root cause: this disposable set was unavailable for specific root cause analysis.A definitive root cause for the observed leukoreduction failure remains undetermined at this time.Possible root causes were provided in the initial report for this event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4357468
• MDR Text Key: 5236045
• Report Number: 1722028-2014-00508
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140158
• 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,Followup
• Report Date: 12/04/2014

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: 09/01/2016
• Device Catalogue Number: 000000000000080400
• Device Lot Number: 09W2125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2014
• 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