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

Catalog Number 80440

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

Data validation investigation: a partially fluid primed trima disposable set with product bags attached was returned to terumo bct for evaluation.Upon inspection, it was observed that the access tubing lines were the only fluid pathways that had been primed through the ac spike, with no fluid found entering back into the cassette access.The sample bag was found inflated fully with air.The white pinch clamp was found closed with tubing found to pucker slightly out of the side of the clamp.Gently handling of the sample bag did not appear to release air into the tubing line while the clamp was closed indicating that the line was properly obstructed.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Terumo bct field performance representative reviewed multiple run data files (rdfs) at the customer's site and the reported incident date for a procedure that matched the reported event.Terumo bct's field performance representative observed one rdf that shown a full collection was not completed.The rdf showed that the procedure started but does not show a donor connected.However, there were no rdfs that indicated the occurence of failed pressure test orair passing through to the sample bag as reported by the customer.Root cause: a definitive root cause for the air in sample bag could not be determined.Based on customer statements and part evaluation, the sample bag was full of air prior to phlebotomy.This indicates that the operator either did not close the sample bag and/or needle line clamps at the system prompt or they did close the clamp but it was skewed on the tubing allowing a portion of the tubing to allow air to pass.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

The customer reported that prior to performing phlebotomy on a donor for a collection procedure, the operator noticed that the sample bag was filled with air.The operator immediately stopped and aborted the procedure.No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information in occupation and corrected information in date of event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6869674
• MDR Text Key: 86601909
• Report Number: 1722028-2017-00375
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170059
• 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
• Report Date: 09/15/2017

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: 07/01/2019
• Device Catalogue Number: 80440
• Device Lot Number: 1707102130
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• 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