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

Catalog Number 80400

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

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

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Correction: no retraining was required as operator acknowledged error and corrected per system prompts.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.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 when the disposable set was lowered on a trima device a pressure test alarm was received.The customer noted the clamp to the sample pouch was opened.Per the customer, they closed the clamp and the cassette was raised using the go back button.The customer removed the air from the sample pouch per the operator's manual before lowering the disposable set a second time.The set was lowered, and the tubing set test was completed without problem.Per the customer they were able to continue the procedure.Patient id, age and outcome are not available at this time.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Corrected 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

No patient (donor) was connected at the time of the event, therefore, no patient information is known for this event.Gender and weight provided in the initial mdr are no longer applicable for this event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6, h.7 and h.10.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.Root cause: based on the customers statement, the root cause was determined to be an operator error, where the sample bag clamp was not closed at the system prompt.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9365089
• MDR Text Key: 188115299
• Report Number: 1722028-2019-00374
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,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: 10/01/2020
• Device Catalogue Number: 80400
• Device Lot Number: 1810245251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 132