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

Model Number 000000000000081000

Device Problems Improper or Incorrect Procedure or Method (2017); Programming Issue (3014)

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

Event Date 06/25/2014

Event Type  malfunction  

Event Description

The customer reported that an operator entered the incorrect height of a donor, which qualified the donor for a single platelet collection.The operator incorrectly entered 6 ft 3 in as the donor's height when the donor's actual height is 5 ft.3 in.Per the customer, the donor did not experience any effects during or after the procedure.No medical intervention was necessary for this event and no additional follow-up was required.Patient's (donor) full identifier: (b)(6).This report is being filed due to a device malfunction in the form of operator error that has the potential for injury.

Manufacturer Narrative

Investigation: per the customer, the procedure was much shorter than normal due to operator error.The donation should have taken 109 minutes, but was completed in 70 minutes.The incorrect entry of the height was not discovered until after the procedure.The donor's tbv was 3487ml and she should have been eligible to donate the 4.0/ 258 ml platelet that was collected but in 109 minutes.The run was completed in 70 minutes.The ac infusion rate was calculated to be > than what the safety box would have allowed (1.2ml/min/liter of tbv) had the correct donor information been entered.The actual infusion rate was 1.286 ml/min/liter of tbv.No on-site machine inspection was performed as this incident was due to operator error.A one year review of service reports did not identify any issue related the reported condition in this report.No additional reports have been received for this device regarding the reported condition.Root cause: the root cause of the reported issue was due to user interface.Correction: a report of operator error issues is distributed each quarter to sales and implementation for potential targeted training.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3955466
• MDR Text Key: 4563260
• Report Number: 1722028-2014-00282
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040086
• 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: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000000000000081000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00056 YR
• Patient Weight: 56