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

Catalog Number 80400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

Lot #, manufacturing date and expiration date of the set are not available at this time.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 double 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 collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

The device history records (dhr) were reviewed for this lot.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.A definitive root cause for the observed leukoreduction failure remains undetermined at this time.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 lrschamber 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.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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5947135
• MDR Text Key: 55013102
• Report Number: 1722028-2016-00520
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• 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: 09/13/2016

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: 06/01/2018
• Device Catalogue Number: 80400
• Device Lot Number: 06Z2120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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