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

Model Number	80440
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: an unused trima set was returned for investigation.The set was received with the two white pinch clamps on the access line closed and the blue pinch clamp open.Visual inspection revealed the damage to one of the side walls on the sidewall pinch clamp.Additionally, on the side of the clamp with the damage, the anvil was not fully occluding the tubing.The set was loaded onto the trima machine in the lab with clamps in their "as found" position.Upon loading of the cassette, a pressure test error alarm occurred and a small amount of air was found in the sample bag.The set was unloaded, and all clamps were opened to represent their original state.The set was reloaded onto the trima machine 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.No alarms or errors were encountered.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 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.
Event or Problem Description
The customer reported a pressure test error alarm during set up of the disposable set for a platelet collection on a trima device.There was not a donor connected at the time of set test, therefore, patient information is not reasonably known.
Additional Manufacturer Narrative
This record is being filed to provide additional information in h.6 and h.10.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h10.Correction: it was confirmed that customer retraining has been completed.Terumo bct clinical support spoke to the customer and explained that one of the white pinch clamps was damaged.The clamp wasn't occluding the tubing and a small amount of air was noticed in the sample pouch.Clinical support explained the importance of the staff properly clamping the tubing and checking for air in the sample pouch.The customer has retrained the staff and updated their sops to address this issue.Root cause: specific root cause was related to an inadequately closed clamp, skewed on the tubing enabling a portion of the tubing to allow air to pass.
Additional Manufacturer Narrative
This report is being filed to provide corrected information in g.4.The become aware date filed in the inial mdr report in g.4 has been corrected to 5/18/2020 as it was identified internally.
Additional Manufacturer Narrative
The become aware date filed in the intial mdr report in g.4 has been corrected to 5/11/2020.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10135622
• Report Number: 1722028-2020-00285
• Device Sequence Number: 2094452
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• 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: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 80440
• Device Catalogue Number: 80440
• Device Lot Number: 1910231130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 08/28/2020; 08/28/2020; 05/18/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 06/30/2020; 09/04/2020; 09/04/2020; 09/11/2020
• 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