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

Catalog Number 82420

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the rdf indicated that 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 presumed 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.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.

Event Description

The customer reported while performing the set installation test ontrima system, they received 'pressure could not be maintained' alarm.However, they passed the 'set installation test' after the second attempt and continued with the procedure.After the venipuncture of the donor,the operator observed no blood flow into the sample bag and after opening the white clamp, it was found that the sample bag was filled with air with only few drops of blood in it.Per customer,no medical intervention is required for this event.Due to eu personal data protection laws, the patient (donor) identifier and age is not available from the customer.Donor gender and weight were obtained from the run data files.Terumo bct is awaiting return of the trima collection set for evaluation.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.Information that was not provided in the initial mdr filing for this event.Investigation: one used trima disposable set was returned to terumo bct for evaluation.Visual inspection confirmed blood present in the sample bag and bonded tubing components ceasing at the sample bag manifold.The sample needle had been removed by the customer and the line rf sealed.All pinch clamps in this area were on the correct lines and in the closed position.The sample bag was noted to have air present inside it.The inlet coil was noted to have fluid present, this fluid was dispersed in segments throughout the coil with air bubbles present.No kinks or misassembled components were noted on the set.All clamps appeared to be functional and no defects were found.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 misassemblies 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 LRS 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: 7650963
• MDR Text Key: 113191238
• Report Number: 1722028-2018-00185
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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: 02/01/2020
• Device Catalogue Number: 82420
• Device Lot Number: 1802281230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2018
• 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: 101