MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS,PLASMA, RBC

Catalog Number 82420

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer provided a picture in lieu of the disposable set to further aid in the investigation.The white clamp on the sample line appeared to have fully occluded the sample tubing line, and the blood diversion bag was fully inflated.Investigation is in process, a follow-up will be provided.

Event Description

The customer reported that during the installation of the trima accel collection kit, the alertmessage appeared, 'error in the line test'.The operator also noticed that the blood diversion bag was full of air.This collection set was unloaded and not used.This occurred at installation, therefore, no donor was connected to the machine.The customer declined to provide donor information.The trima collection set was not available for return because it was discarded by the customer.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

This report is being filed to provide additional information.Correction: terumo bct provided retraining to the customer regarding this incident.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) was analyzed for this event.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Upon photographic inspection, it was observed that the pinch clamp not appeared to be defective, as it was occluding the line as intended.Root cause: the ¿pressure test error¿ alert was generated during the first tubing set test in this procedure because the expected pressure increase was not seen in the allotted volume pumped.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.Based on the picture provided by the customer and the run data file analysis, either the sample bag clamp 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.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

The patient's gender and weight were obtained from the run data file (rdf).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS,PLASMA, RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7898217
• MDR Text Key: 121722578
• Report Number: 1722028-2018-00260
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

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: 04/01/2020
• Device Catalogue Number: 82420
• Device Lot Number: 1804111230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 10/08/2018; 10/25/2018
• Supplement Dates FDA Received: 10/16/2018; 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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 Weight: 61