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

Catalog Number 80520

Device Problem Material Integrity Problem (2978)

Patient Problem Hemolysis (1886)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the unit segments of both bags of a double red cell (drbc)product were observed at distribution to have a red color the customer described as hemolysis.The units themselves did not have the same red color.Hemolysis testing was not performed.The rbc products were not issued for transfusion and were discarded.No medical intervention was necessary for this event and no follow-up visit was required.The patient (donor) is 'fine'.Patient (donor) full identifier: (b)(4).The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with event based on additional investigational information.Based on the customer statements, the hemolysis was not seen in the rbc product bags.The customer reviewed the collection with the operator and the operator reported that there was no hemolysis during the procedure and no problems with the run.The visual hemolysis was only seen in the segment samples.Therefore,the disposable set and system is not the source of this issue.The disposable set was unavailable for return.The customer declined a service call because they stated that the collection procedure had no issues.The issue was with the products post collection.A review of the procedure summary shows that there was only one alert for draw pressure too low.There were no alerts or end run messages indicating issues with hemolysis.Root cause: according to customer description, the visual hemolysis was found only in the samples and not in the drbc units themselves.The operator stated that there were no issues with hemolysis during the procedure and no problems with the run itself.The cause for the hemolysis in the segments is inconclusive but possible causes include how the sample segments were handled and/or stored.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTO RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5021645
• MDR Text Key: 24709096
• Report Number: 1722028-2015-00498
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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: 80520
• Device Lot Number: 06Y3230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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
• Patient Age: 31 YR
• Patient Weight: 84