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

Catalog Number 80400

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that the operator loaded and primed the trima disposable set correctly.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during a donation procedure, the operator observed air at the donor needle.While connecting the donor to the trima disposable set, the operator noticed that the sample bag was filled with air prior to phlebotomy.Per the customer, when the operator opened the white clamp, she noticed reversed flow and heard a "rush"of air into the disposable set.The operator stopped the procedure and disconnected the donor immediately.Post donation, the donor was asymptomatic and discharged home.Approximately 15 minutes later after the donor leaving the customer's site, she called and complained of feeling shortness of breath and coughing, however, no medical intervention was given to the donor.On the following day, the customer followed up with the donor and she stated that she was"fine".The donor is reported in heathy and stable condition.(b)(6).The trima collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

(b)(4) mechanical evaluation.This report is being filed to provide additional information.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Terumo bct service technician visually inspected the machine and performed a bi-annual preventative maintenance (pm) procedure as per manufacturer's specifications and found no anomalies.An internal capa has been initiated to evaluate reports of air in sample bag.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: a definitive root cause could not be determined.The ¿pressure test error¿ alert indicated that the operator either did not close the sample bag and/or needle line clamps at the system prompt, or, did close the clamp, however skewed, and not properly occluding the tubing.Air will enter the sample bag during the verification of clamp closure at the beginning of the tubing set test if the sample bag clamp is not fully closed.If this occurs, the trima accel system will alert the operator to a failure during the tubing set test.This alert will instruct the operator either to express air from the sample bag if it is inflated, or to verify that no air is in the sample bag.Information screens on the trima accel machine are accessible from the alert screen will instruct the operator how to express air if the sample bag is inflated.It is possible, though not conclusive; the operator did not express the air that entered the sample bag as prompted by the trima accel display screen.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewod, CO 80215 ; 3032392246
• MDR Report Key: 7040794
• MDR Text Key: 93257414
• Report Number: 1722028-2017-00444
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160116
• 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,Followup,Followup
• Report Date: 11/17/2017

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: 05/01/2019
• Device Catalogue Number: 80400
• Device Lot Number: 1705115151
• Other Device ID Number: 05020583804005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 03/26/2018; 04/06/2018
• Supplement Dates FDA Received: 04/06/2018; 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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: 63 YR
• Patient Weight: 72