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

Catalog Number 80440

Device Problems Air Leak (1008); Use of Device Problem (1670)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the trima collection set was returned with detached platelet collection bag and sample bag for investigation.Upon visual inspection, it was noted that the sample bag was inflated with air and contained approximately 10 ml of blood.The white clamp on the sample line was found in the closed position upon return.The sample line was disconnected from the access coil and pressurized via a syringe to test the clamp performance.Manual pressure of water was unable to clear the closed clamp.Air was then applied to the line at approximately 20 psi, with no leak found through the clamped line.Investigation of the sample bag line confirmed a full obstruction of the tubing line with the clamp closed in the position it had been received from the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that at the beginning of collection procedure, the operator observed small air bubbles moving into the sample bag and noted a large amount of air in the sample bag.The operator stopped and aborted the procedure without rinseback.The customer stated that the donor was discharged from the customer site and no medical intervention was required for this event.(b)(6).Patient (donor) weight is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a run data file was analyzed for this event.Terumo bct reviewed the run data file and confirmed that there was a pressure test error during the disposable set test.The procedure was ended almost immediately after the procedure was started.Root cause: root cause for air in the sample bag remains undetermined at this time.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.It is possible, though not confirmed, that the air remained in the sample bag when the set was reloaded and the tubing set test passed because the sample bag was almost fully inflated or because the clamping issue was resolved upon unload without removing the air.The returned set was evaluated and no defects or mis-assemblies were found.This combined with the run data file analysis indicate that either the sample bag and/or needle line clamps was not closed at the system prompt or the clamp was closed but it was skewed on the tubing allowing a portion of the tubing to allow air to pass.

• 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: 7316675
• MDR Text Key: 101866688
• Report Number: 1722028-2018-00061
• 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,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 80440
• Device Lot Number: 1708255151
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2017
• 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: 59 YR
• Patient Weight: 112