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

Catalog Number 80337

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The 'pressure test error' alarm was confirmed.Based on the analysis of the rdf, it is suspected that the pressure increase was not sufficient because the pinch clamp on the sample bag line was likely not occluding the line properly.If the clamp on the sample bag line is not occluding the line properly during the tubing set test, air can have a pathway to enter the sample bag.The rdf analysis also showed that the operator was able to continue from the ¿pressure test error¿ alert after opening the clamps which allowed the pressure in the tubing set to return to normal.Once the operator continued from the ¿pressure test error¿ alert, the tubing set test completed with the expected signals.It is assumed after the operator continued from the alert, the clamps were all fully occluding the lines and therefore the tubing set test passed successfully.At the prompt to connect anticoagulant, however, the operator chose to terminate the procedure.No donor was connected.The disposable set was received for evaluation.The set was loaded on a machine to try to reproduce the customer's claim of air in the sample bag line.No issues were noted with the returned set.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported that during set up for a collection, a 'pressure test error' was displayed on the machine and the operator found air in the sample bag tubing.No donor was connected at the time that air was seen in the tubing, therefore, no patient (donor) information is reasonably known.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

Investigation: 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 ¿pressure test error¿ alert was generated in this procedure because the expected pressure increase was not seen in the allotted volume pumped during the tubing set test.Based on the analysis of the run data file, it is suspected that the pressure increase was not sufficient because the pinch clamp on the sample bag line was likely not occluding the line properly.If the clamp on the sample bag line is not occluding the line properly during the tubing set test, air can have a pathway to enter the sample bag.Run data file analysis showed that the operator was able to continue from the ¿pressure test error¿ alert after opening the clamps which allowed the pressure in the tubing set to return to atmospheric.Once the operator continued from the ¿pressure test error¿ alert, the tubing set test completed with the expected signals.It is assumed after the operator continued from the alert,the clamps were all fully occluding the lines and therefore the tubing set test passed successfully.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

• 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: 5890143
• MDR Text Key: 53662730
• Report Number: 1722028-2016-00462
• 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
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

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: 06/01/2018
• Device Catalogue Number: 80337
• Device Lot Number: 06Z0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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