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

Catalog Number 80337

Device Problems Air Leak (1008); Device Difficult to Setup or Prepare (1487); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

Method: data validation investigation: the disposable set was returned for evaluation.Upon visual inspection, the customer's report of air in the sample bag was confirmed.A root cause could not be determined from this evaluation.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Based on the analysis of the rdf and the complaint description, it is suspected that air entered the sample bag when the ¿tubing set type error¿ alert first occurred during the disposable test.This alert was generated as the expected pressure value increase was not seen when pressurizing the set.Instead the pressure value remained constant indicating a different tubing set was loaded.This was likely caused by a skewed pinch clamp that was not fully occluding the sample bag line.If the clamp on the sample bag is not occluded properly during the disposable test, air can enter the sample bag.After clearing the alarm, it is assumed the operator reloaded the same disposable due to the immediate timeframe.The tubing set successfully passed the disposables test and continued through to the connect donor screen where the run was ended by the operator.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during set up of the disposable set, they received a tubing set type error alarm so the operator unloaded the cassette.When the operator tried to set up again they noticed air in the sample diversion bag.Patient (donor) information is unavailable from the customer due to (b)(6) privacy protection laws.The patient's gender and weight were obtained from the run data file.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Root cause: based on the analysis of the run data file (rdf) and the complaint description provided by the customer, the possible root cause wa provided in the initial report.Correction: a voluntary medical device product recall was released by terumo bct on (b)(6) 2014 to communicate more information about the "air in the sample bag safety alert" to the customer.Corrective/preventive action: an internal capa has been initiated to address corrective and preventative actions for air in the sample bag.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: pressure testing was performed on the returned disposable set to see if the white clamp was allowing air into the bag even while closed.No air was able to go in which confirmed the clamp was closed enough, at least at the time of receipt.It is not known if the clamp was completely closed at the customer site and would be a possible way for the air to enter the sample bag during the run.The amount of air within the sample bag was measured and contained approximately 35 ml.No occlusions, misassemblies or other defects were found with the set.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause continued: based on the available evidence, the root cause is a pinch clamp that was not fully occluding the sample bag line.Additional information: terumo bct's sales representative followed-up with customer and explained the possible failure modes and the necessary actions to be performed by the customer if air is in the bag, and risks to the donor.The operator¿s manual also includes a caution to confirm that no air is present in the sample bag before connecting the donor.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, 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: 5104357
• MDR Text Key: 26956419
• Report Number: 1722028-2015-00564
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 09/01/2015

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: 80337
• Device Lot Number: 06Y0301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/04/2015; 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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 Weight: 73