MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER, AUTO PAS, MLTPLS SET

Catalog Number 82310

Device Problems Use of Device Problem (1670); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during set-up for a platelet and plasma donation procedure, air went to the sample bag.The set had to be unloaded and the customer reported no alarm occured.There was no donor connected at the time of the incident, therefore patient (donor) information is not reasonably known.Terumo bct is awaiting return of the disposable set.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 in d10, h3, h6 and h10.Investigation:the customer returned one used trima set containing prime fluid for investigation.The access needle was examined and there was no evidence that the set had been connected to a donor.The ac line drip chamber and sterile barrier filter were removed from the set and not returned.Visual inspection noted that the donor line pinch clamps were located on the correct lines, flossed onto the tubing correctly and in the closed position, however the 'blue sealing collar' was noted to interfere with the closure of the sample bag line sidewall clamp.The sample bag was significantly inflated with air.The sidewall clamp was inspected for damage and a minor impression was identified on one side of the component.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the customer was retrained at their site by terumo bct account manager.They were advised of the issue and confirmed understanding.Trima field action 35 has been initiated to notify all trima users of a potential safety hazard occurs if the system displays an alert and instructions are not observed and followed.Terumo bct is taking corrective action by reminding all users of the action to be taken to mitigate this risk.Alerts and instructions are presented to the operator if the sample bag inflates.Terumo bct instructs all trima users to provide supplementary training and to continue to use the trima accel system in accordance with the operator¿s manual.Corrective action: an internal capa has been initiated to address pinch clamp not occluding the sample bag line consistently.Root cause: based on the evaluation of the returned set, the cause for air in the blood diversion bag is a clamping error where the clamp skews to the side as it is closed, enabling a portion of the tubing to allow air to pass.Another possible cause relates to the movement or positioning of the blue sleeve to a location on the sample line where it affects the ability of the clamp to occlude the line, either by the customer or during the manufacturing process.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER, AUTO PAS, MLTPLS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10448382
• MDR Text Key: 206586692
• Report Number: 1722028-2020-00403
• 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
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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: 06/01/2022
• Device Catalogue Number: 82310
• Device Lot Number: 2006161230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other