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

Model Number 82410

Device Problems No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012); Unexpected Shutdown (4019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the machine spontaneously shut down and the screen went black.The operator turned it off and on and started again.When she was entering the donor information, the screen suddenly went blue.The tubing set was already in place and the operator turned off and on again.Failure "# 61" appeared on the screen.The tubing set was removed after several attempts.A new set was set up and it did not pass the pressure test.Pet the customer, the cassette was properly positioned, the lines were on the pumps, the white clamps were closed, and the air was removed from the sample bag.These steps were repeated several times.Patient information and outcome are not available at tis time.The disposable set is not available for return because it was discarded by the customer.

Event Description

The procedure was discontinued prior to connecting a donor, therefore, patient information is not reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, b.5, h.6 and h.10 investigation: the customer submitted 4 photos to aid in the investigation.The first 3 images are screenshots following the alarms, which include the alarm description and directions for the operator.The 4th image is the disposable set loaded onto the cassette and lowered down around the pumps.The set does not contain fluid; no abnormalities are observed.The lines, clamps, and bags beyond the set are not visible.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Alarm (61) air removal failure.Pressure detected during bag evacuation ending run is generated when the evacuation pressure alert has been triggered for a third time.Preventive maintenance was performed on (b)(6) 2020.The device was verified to be operating per manufacturer specifications.Root cause : a specific root cause for the air in the sample bag could not be 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.A reboot of the system is a designed response to any unknown or abnormal state in any of the systems on the device.The root cause for the reported reboots in this incident could not be determined.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.

Manufacturer Narrative

This report is being filed to provide additional information in e.1.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET AUTO PAS, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10482494
• MDR Text Key: 206186147
• Report Number: 1722028-2020-00421
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: 82410
• Device Catalogue Number: 82410
• Device Lot Number: 1903252130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other