MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC AND PLASMA SET

Catalog Number	80500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional 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.An unused trima set was returned to terumo bct for investigation.It is noted that the two white pinch clamps on the access assembly were closed upon receipt of the set, and the blue clamp was open.Visual inspection for kinks, occlusions, missing parts, mis-assembly or leaks which may have contributed to the reported incident and no anomalies were found.All pressure sensors were inspected and determined to be functioning properly.The set was loaded onto the trima machine in the lab and all on screen prompts for clamping were followed.The set passed loading, tubing set test and made it to the connect ac stage.The procedure was halted at this point and the set was unloaded.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 or Problem Description
The customer reported that during setup for a procedure on the trima device during the tubing set test, they received alarm (61) "air removal failure - pressure detected during bag evacuation ending run".Per the operator the bag was clamped a little late.The set was removed and not used.The donor was moved to another device.No patient (donor) was connected at the time of the event, therefore no patient information is reasonably known.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6, h.7 and h.10 and corrected information in e.1.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.An email was sent from terumo bct customer support to the customer advising them of the user error and inquiring if they would like additional training for this issue.To date, the customer has not responded to the request.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp not effectively occluding the sample bag line consistently and air in the sample bag.Root cause: per the customer's statement, the root cause was determined to be the result of a user interface error where the sample bag clamp was not closed at the system prompt.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9365216
• Report Number: 1722028-2019-00376
• Device Sequence Number: 13602016
• Product Code: GKT
• UDI-Device Identifier: 05020583805002
• UDI-Public: 05020583805002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 80500
• Device Lot Number: 1906061330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other