MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

Model Number 81000

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 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a service call was placed and a service technician checked out the trima machine at the customer site.Upon visual inspection, it was noted that the red blood cell (rbc) detector required cleaning and recalibration.The rbc detector was cleaned and recalibrated.The machine was returned to service.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 wbc testing, therefore, no patient information is reasonably known at the time of the event.Wbc count is not available at this time.

Manufacturer Narrative

Root cause: signals in the run data file (rdf) indicated that the trima device operated as intended by flagging the procedure to verify wbcs.Moreover, the device alarmed as designed and the device failed safe with an alarm.As the customer reported that the trima device was flagging the product for wbc contamination testing due to red cell spillover alerts during prime, the root cause of the red cell spillover alerts was due to a dirty or miscalibrated rbc detector.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: 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 this event based on additional investigational information.Signals in the run data file (rdf) indicated that the trima device operated as intended by flagging the procedure to verify wbcs.Moreover, the device alarmed as designed and the device failed safe with an alarm.The device serial number history report indicated that no further related issues have been reported for this device.A review of the last year of service history for this device indicated no other reports related to this issue.Investigation is still in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7311270
• MDR Text Key: 101700696
• Report Number: 1722028-2018-00060
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: BK080058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81000
• Other Device ID Number: 05020583810006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2009
• 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