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

Model Number	82400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a disposable history search confirmed there were no similar occurrences reported on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrective action: an internal capa has been initiated to address pinch clamp no occluding the sample bag line consistently.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.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during set up for a procedure, the sample pouch filled with air twice.A donor was not connected at the time of the event, therefore, no patient information is reasonably known.The disposable set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in e.3, h.6 and h.10.Corrected information is provided in b.3.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
• Common Device Name: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10706657
• Report Number: 1722028-2020-00480
• Device Sequence Number: 16977514
• Product Code: GKT
• UDI-Device Identifier: 05020583824003
• UDI-Public: 05020583824003
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 06/01/2022
• Device Model Number: 82400
• Device Catalogue Number: 82400
• Device Lot Number: 2006101330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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