MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEN

Model Number 81000

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/06/2014

Event Type  malfunction  

Event Description

The customer reported that approximately 20 minutes into a collection procedure, the trima machine restarted with no alarms.The machine then alarmed 'safety detected donorhypovolemia'.The operator ended the procedure.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.Upon visual inspection and flow testing, no defects or misassemblies were noted.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

There is no safety risk associated with the reported condition.A reboot of the system is a designed response to any unknown or anomalous state in any of the systems on the device.The device is placed into a safe state by its safety and/or control computers.No fluid can be drawn or returned to the donor in this state.Resulting fluid removed during the procedure was 328ml or (b)(6) of the donors tbv.This is an known rare software issue.An internal i & d tracking number has been assigned to this record for investigation of possible future software revisions.No further related issues have been reported for this device.Root cause: software issue.

Manufacturer Narrative

Investigation: the service history for the past year was evaluated and there was no previous service that could reasonably contribute to the reported condition.The run data file (rdf) was analyzed for this event.Signals in the run data file show a timing problem.The platelet collect valve was moving from no platelet collection to platelet collection at the time the operator was adjusting the draw flow down.The timing of these two events caused the platelet collect valve to not finish its movement and the safety computer shut down the procedure.As this is a timing issue, it is very hard to reproduce and should be expected to occur at an extremely low rate in the future.Investigation is in-process.A follow-up report will be provided.

Event Description

The gender and weight of the patient were obtained from the run data file.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately of the mdr form.This supplement is being filed to modify information to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEN
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4061356
• MDR Text Key: 17999894
• Report Number: 1722028-2014-00360
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK040086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: 81000
• Device Catalogue Number: 000000000000080483
• Device Lot Number: 05W2121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 09/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/27/2014; 11/17/2014; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 53