MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET PLT FILTER AUTO PAS PLASMA SE

Catalog Number 82383

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: one complete unused trima disposable was returned to terumo bct for investigation.Initial observations noted that the inlet, sample bag, pas and lr filter pinch clamps were all in the closed position.No air was observed within the diversion bag at the time of receipt.The disposable set was visually examined for any kinks, missing parts or other misassembly and none were found.The disposable set was loaded onto a trima device as received and the pressure test commenced.A pressure test failure alarm was received and it was noted that the diversion pouch was filled with air, indicating that the white side wall pinch clamp was not effectively occluding the tubing line.An internal capa have been opened to examine sidewall pinch clamp not occluding the sample bag line consistently.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during setup of a trima device, they received a "high pressure" alarm.Per the customer, they were not able to unload the set and the customer notified the technician and the set was unloaded.Upon receipt and evaluation testing by terumo bct of the trima set, a pressure test failure alarm was received and it was noted that the diversion pouch was filled with air, indicating that the white side wall pinch clamp was not effectively occluding the tubing line.Patient information and outcome are unknown at this time.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.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

Event Description

No patient (donor) was connected at the time of the event, therefore, no patient information is known.Eu personal data protection laws are in effect for this event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6, h.7 and h.10.Corrected information is provided in a.1, b.5 and h.6.Investigation: during follow-up with the customer, it was reported that there was no visible air bubbles noticed at the customer site, there was only an unloading issue.Correction: 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 have been opened to examine sidewall pinch clamp not occluding the sample bag line consistently and air in the sample bag.Root cause: specific root cause could not be definitively determined for this incident.Possible causes include: a clamp malfunction where the clamp skews to the side as it is closed, or the clamp does not fully occlude the tubing when closed due to interference between the clamp and the tube.Additional contributing factors could be related to user interface, where either the sample bag clamp was not closed at the system prompt or the clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET PLT FILTER AUTO PAS PLASMA SE
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9279230
• MDR Text Key: 189084166
• Report Number: 1722028-2019-00330
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2019

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: 05/01/2021
• Device Catalogue Number: 82383
• Device Lot Number: 1905062130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 11/04/2019; 12/30/2019
• Supplement Dates FDA Received: 11/26/2019; 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other