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

Model Number 917000000

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the centrifuge door would not lock.She was able to open the door while the procedure was running.The clinical call specialist instructed the customer to rinse back the donor immediately and to not touch the door until the centrifuge had stopped.Operator outcome is not available at this time, however, no injury was reported for this event.Operator age and weight are not available at this time.Donor weight was included in patient weight section due to a system limitation.

Event Description

This report documents a failure of the device which creates a potential for injury.No donor or operator injury was reported for this specific incident.

Manufacturer Narrative

Investigation: service was sent on-site.The service representative was unable to confirm the reported condition.A full system check out was performed with no issues identified.As a precaution, the solenoid position sensor and solenoid for the door latch mechanism was replaced.An auto test and saline run were performed to verify function of the device.Review of the run data files shows a 'door open/centrifuge cannot run' alarm at the beginning of the run.Based on the run data file, the failure was likely caused by a loose connection from the control cca.The loose connection may have been resolved when the service technician checked for loose connections during the full system check out.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10 and corrected informantion in a.1.Updated investigation: the parts that were proactively replaced were not returned to terumo bct for evaluation.Review of the run data files shows a 'door open/centrifuge cannot run' alarm at the beginning of the run which is due to the following conditions: - the centrifuge door is not fully closed or had an obstruction - the centrifuge door open optical sensor or hall effect sensor is defective - a magnet is missing from the door latch assembly - door not aligned root cause : the specific root cause of this failure could not be determined.Based on the service report and the alarm found in the run data file, possible causes include, but are not limited to: - the centrifuge door was not fully closed or had an obstruction - the centrifuge door open optical sensor was defective and/or - the hall effect sensor was defective.

Event Description

No patient information is reasonably known at the time of the event as no injury or medical intervention occured.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11901299
• MDR Text Key: 256179622
• Report Number: 1722028-2021-00198
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK030083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

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 Model Number: 917000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 07/22/2021; 08/09/2021
• Supplement Dates FDA Received: 08/04/2021; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95