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

Model Number	82300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the customer returned one complete, unused trima accel lrs platelet set for investigation.Initial observations noted that all pinch clamps were in the closed positions.The sample bag and vent bags are both deflated, packaging impressions are apparent on the vent bag.The white pinch clamp present on the sampling bag inlet tubing and the donor line tubing are both closed, completely occluding the tubing.The blue pinch clamp on the inlet line tubing, proximal to sample bag manifold is in the closed position, however, the tubing is not completely occluded.All clamps were opened, and the set was loaded onto the laboratory trima device, all on screen prompts were followed however a pressure test alarm occurred, confirming the reported event.No kinks, occlusions or disassemblies were noted on the returned set.Investigation is in process.A follow up report will be provided.
Event or Problem Description
Per the customer, during the tubing set test of setup for the procedure on a trima device, air was noted in the disposable set sample bag.Per the customer, they received repeated pressure alarms, even after restarting the device.The set was removed and a new disposable set was used without any problems.There was not a patient connected to the device at the time of setup, therefore no patient information is reasonably known.
Additional Manufacturer Narrative
Investigation: the device history record was reviewed for this lot.There were no issues noted that would have contributed to the event.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.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 address pinch clamp no occluding the sample bag line consistently.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10077060
• Report Number: 1722028-2020-00241
• Device Sequence Number: 2924950
• Product Code: GKT
• UDI-Device Identifier: 05020583823006
• UDI-Public: 05020583823006
• Combination Product (Y/N): N
• PMA/510(K) Number: BK180231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: 12/01/2021
• Device Model Number: 82300
• Device Catalogue Number: 82300
• Device Lot Number: 1912284151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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