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

Catalog Number 80337

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file showed that the disposable tubing set was loaded at both set loads.Analysis also showed that the alerts generated were ¿tubing set type error¿ and ¿pressure test error¿.These alerts will be generated when the expected pressure increase is not seen by the system during the tubing set test.The ¿tubing set type error¿ alert was generated because the pressure reading indicated to the system that a different tubing set was loaded as it was at a consistently lower value.(b)(6) only uses one type of tubing set with the trima system and it is not an auto rbc type as the alarm screen indicates.There are other reasons this alert can be generated than what is currently listed on the ¿tubing set type error¿ alert screen.The ¿pressure test error¿ alert was generated because the pressure reading could not increase to the target.The alert screen for the ¿pressure test error¿ better describes the possible causes for both itself and the ¿tubing set type error¿ alert.Both of these alerts may be generated if the clamps on the needle or sample bag lines are not occluded properly during the tubing set test, the kit is not loaded properly onto the machine, or if there is an integrity issue with the kit.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.Patient (donor) information is unavailable from the customer due to (b)(6) privacy protection laws.Terumo bct is awaiting return of the disposable set for evaluation.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.

Manufacturer Narrative

A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The complete disposable set with an inflated sample pouch was returned for investigation.Upon visual inspection, it was noted that the clamps were properly closed.No misassemblies or defects with the set were observed.The air was removed from the bag using a graduated cylinder with a result of approximately 116 ml of air.Root cause: the rdf analysis indicates clamping of the inlet coil did not occur as required by the operator and allowed air to build up in the sample bag.Based on the available evidence, the root cause is a 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.Corrective action: an internal capa has been initiated to evaluate reports of air in sample 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.

Manufacturer Narrative

This report is being filed to provide additional information.The closure letter for this event was provided to the customer on 01/26/2016 in person by the sales representative.The user interface issue was explained at that time.

Event Description

There was not a patient (donor) connected at the time of the event, therefore, no patient(donor) information is reasonably known.

• 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: 5313883
• MDR Text Key: 34757730
• Report Number: 1722028-2015-00666
• 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: Initial,Followup,Followup
• Report Date: 12/21/2015

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: 09/01/2017
• Device Catalogue Number: 80337
• Device Lot Number: 09Y0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/15/2016; 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2015
• 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