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

Catalog Number 80337

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The reported alarm was confirmed in the rdf.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the ¿tubing set type error¿ alert was generated because the pressure reading was consistently at a lower value, which could be an indication to the system that a different tubing set was loaded or that the needle or sample bag clamps were not occluding the lines properly.Since (b)(6) customers only use one type of tubing set with the trima system, it is likely that the pressure difference was due to an issue with a clamp not fully occluding the tubing.This was confirmed by the customer statement that the white pinch clamp needed to be re-closed in order to continue the procedure as well as letting the air out of the diversion bag.Correction: a voluntary medical device product recall notice was distributed to customers detailing the possible failure modes, necessary actions to be performed by the customer if air is in the bag, and risks to the donor.The customer was contacted by a terumo bct's sales representative on (b)(6) 2016 and the user interface issue was explained.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

The customer reported that during setup for a collection procedure, they received a 'tubing set type' error alarm and noted air in the sample bag.The customer stated that the air was removed from the sample bag and the white pinch clamp was re-closed on the sample bag.No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.The disposable kit is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, 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: 5477847
• MDR Text Key: 39883980
• Report Number: 1722028-2016-00100
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 03/03/2016

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: 12/01/2017
• Device Catalogue Number: 80337
• Device Lot Number: 12Y0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• 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