MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTO RBC AND PLASMA SET

Catalog Number 80520

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Filtration Problem (2941); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher than expected wbc content in rbc 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 is possible that the filter was unloaded from the filter bracket and loaded again during rbc collection or rbc additive solution addition, which could have a similar effect to ¿squeezing¿ the filter when using a gravity drain system.It is also possible that the reported results could be attributed to an issue with the filter.Investigation is in progress.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 red blood cell (rbc) product.Product was discarded.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 not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: 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 white blood cell (wbc) count experienced by the customer.Root cause: a definitive root cause for the observed leukoreduction 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 red blood cell(rbc) 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, itis possible that the filter was unloaded from the filter bracket and loaded again during rbc collection or rbc additive solution addition, which could have a similar affect to ¿squeezing¿ the filter when using a gravity drain system.It is also possible that the reported results could be attributed to an issue with the filter.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTO RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5815943
• MDR Text Key: 51121638
• Report Number: 1722028-2016-00422
• 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,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• 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: 80520
• Device Lot Number: 10Y3327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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