MAUDE Adverse Event Report: TERUMO BCT INC. TRIMA ACCEL SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Device Problem Computer Software Problem (1112)

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

Event Date 05/03/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, the terumo bct trima accel system (device sn (b)(4)) allowed an apheresis operator to collect a 2rbc (double rbc) product (bag 1 was 326ml and bag 2 was 432ml) and a 264ml plasma, this procedure is not one that is on our procedure list and is not one that would ever be elected to perform.Although the operator initially selected a plasma procedure, 19 minutes into the procedure, the device allowed the operator to change the procedure to a 2rbc with single plasma.Following the collection, the operator reported what happened to his manager and the quality department and an investigation began.A root cause analysis event was held on (b)(6) 2017 internally at inova blood donor services regarding the procedure and the incident was reported to terumo for further investigation.Terumo's report took several days and their final stance on the procedure was that the "trima accel acted as intended" and their organization had observed issues similar to this in the past but didn't feel there was a need to notify any customers or change any of their business practices.

• Brand Name: TRIMA ACCEL SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT INC.
• MDR Report Key: 6621499
• MDR Text Key: 77221179
• Report Number: MW5070244
• Device Sequence Number: 1
• Product Code: GKT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 99