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

Catalog Number 80500

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer the units are cooled with coolant blocks for transportation.Bubble wrap and cooling blocks are used to insulate the units.The units were filtered with an haemonetics leukotrap scrc.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the hemolysis experienced by the customer.The procedure summary was analyzed for this event.The procedure summary showed no alerts,errors or adjustments made during the collection.Root cause: a definitive root cause for the reported hemolysis could not be determined.According to customer statements, the hemolysis was not noted directly after collection.Hemolysis was visibly noted after filtration with the filtration done on a non-terumo bct device.Therefore, the trima disposable and system are not the cause of the reported hemolysis.Possible causes for the hemolysis include but are not limited to rbc filtration procedures, filtration device,product storage, and/or product handling.

Event Description

The customer reported seeing hemolysis in the segments following a double red blood cell(drbc) product collection.It was discovered post filtration.Per the customer, hemolysis was not noted in the segments pre-filtration.Post filtration, based on visual inspection, the unit had a definitive red tinge.The segments were spun again with the same results.The customer stated that the product was not transfused and was discarded.There was not a transfusion recipient or patient involved at the time of this unit processing,therefore no patient information is reasonably known at the time of the event.Donor identification #: (b)(6) the disposable kit is not available for return, because it was discarded by the customer.

• 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: 5563568
• MDR Text Key: 42972408
• Report Number: 1722028-2016-00177
• 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
• Report Date: 04/08/2016

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: 06/01/2017
• Device Catalogue Number: 80500
• Device Lot Number: 06Y1223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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