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

Catalog Number 80440

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the appearance of rbcs in the platelet 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 cannot be ruled out that the observed results in the platelet product could be donor-related.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 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 the event.Donor unit #: (b)(6).Wbc count is not available at this time.The platelet collection is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide clarifying information and additional information.Investigation: wbc count of the product is not known.Per the run data file analysis, the trima displayed the message that the platelet product could be labeled as leukoreduced.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the event experienced by the customer.The set was not saved for investigation since the unfavorable appearance of product was not until after collection and resting.A photo provided by the customer shows a picture with red blood cell (rbc) contamination settled out in the unit.A clear settling of rbcs can be seen in the picture.Root cause: the analysis of the run data file did not find a conclusive cause for the appearance of rbcs in the platelet 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.

Event Description

Clarification of the event: the customer reported a collected platelet product failed qc due to its appearance.The customer stated there appeared to be red blood cells in the product.The customer discarded the product and did not perform qc testing.Therefore, white blood cell content in the product is not known.

Manufacturer Narrative

This report is being filed to provide corrected information.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7427285
• MDR Text Key: 105773260
• Report Number: 1722028-2018-00096
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170059
• 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,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 80440
• Device Lot Number: 1802071330
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2018
• 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
• Patient Weight: 90