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

Model Number 81000

Device Problems Data Problem (3196); Patient Data Problem (3197)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the rdf analysis, the procedure that was run with incorrect donor weight resulted in ~17%tbv being collected.The ac infusion rate was calculated to be ~1.32ml/min/ltbv, which is > the trima maximum of 1.09ml/min/l tbv.No adverse events occurred during or after the donation and the donor has donated since this incident.A one year review of the device's service history was performed with no issues noted related to the reported condition.The terumo bct clinical specialist provided feedback to the customer regarding the implications of incorrect data entry of donor information and how it can affect available procedures.Corrective action: an internal capa has been initiated to address data entry errors.Root cause: the root cause of the incorrect donor weight was an user interface issue.

Event Description

During review of run data files (rdfs) for an unrelated customer request, terumo bct found an incident of donor data entry error.In the rdf, it was noted that the weight of a donor had been entered incorrectly.No medical intervention was required for this event.Actual weight: (b)(6) full donor (b)(6).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5386110
• MDR Text Key: 36740999
• Report Number: 1722028-2016-00023
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/22/2016

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: 81000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 63