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

Catalog Number 82310

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2019

Event Type  malfunction  

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.One unused trima disposable set was received by terumo bct for investigation.Initial observations noted that the white pinch clamps on the access needle, diversion bag, sampling assembly and the yellow pinch clamp on the auto pas line were all in the closed position.The slide clamps on one of the plasma bag lines, the secondary platelet collect bags and the sampling assembly were also noted to have been closed.The disposable set was loaded onto a trima device and the tube set, and pressure tests were commenced; a 'tube set type' error message was received.All clamps were returned to the open position and the procedure was rerun following the onscreen prompts.The disposable set successfully passed the subsequent tube set and pressure tests continuing onto the ac connect screen.The disposable was further examined for any kinks or other manufacturing defect and none were identified.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp.Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

The customer reported that during the setup of the disposable set on a trima device, the device made "strange noises" and they received an air alarm.Per the customer the white clamp was closed, and the sample bag was ventilated.The same disposable set was unloaded and tried again with the same problem.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.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 h.6, h.7 and h.10.Correction: during follow-up with the customer, the customer acknowledged the experience of their operators and stated that all operators are well training and have great experience with trima.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.Updated corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp 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,SAMPLER, AUTOPAS, MULTIPLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9364999
• MDR Text Key: 188115713
• Report Number: 1722028-2019-00373
• 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
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 82310
• Device Lot Number: 1904241230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other