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

Model Number 81000

Device Problem Patient Data Problem (3197)

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

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the error was discovered upon a routine quality assurance review of the apheresis records at the customer's site.Based on the calculated anticoagulant infusion rate for the donor's actual total blood volume vs the entered total blood volume, it is unlikely that the donor for this procedure received an a cover infusion resulting from the incorrect gender being entered into the trima accel system.A one year review of the device's service history was performed with no issues noted related to the reported condition.An internal report shows that the machine has been in use with no further occurrences of the problem.Terumo bct's clinical specialist provided feedback to the customer regarding the implications of incorrect data entry of donor information.Root cause: the root cause has been determined to be a user interface error.

Event Description

The customer reported an incident of data input error in the trima system.A triple platelet collection procedure was being performed on a female, but the gender was entered as a male in the system.Per the customer, the procedure was completed with no issues and the donor did not experience any adverse reactions.Patient's (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: 5414386
• MDR Text Key: 38218080
• Report Number: 1722028-2016-00049
• 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: 02/05/2016

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: 01/13/2016
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2009
• 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: 53 YR
• Patient Weight: 99