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

Model Number 000000000000081000

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/27/2014

Event Type  malfunction  

Event Description

The customer reported an incident of data input error in the vista software system.Approximately 10 minutes into the procedure, the operator realized he had entered a larger donor's information, but then connected a smaller donor for the procedure.The procedure was ended after running for 23 minutes.Patient information is not available at this time.This report is being filed due to device malfunction, in the form of operator error, that has the potential for injury.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Per the rdf, the ac infusion rate did not exceed the 1.2 ml/min/tbv safety limit.The highest ac infusion reached was.75479 ml/min/tbv.The calculated actual limit for the donor was.88323 ml/min/tbv.A one year device history review was performed with no issues related to the reported condition found.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: per the customer, they were able to merge the procedure to the correct donor following the initial discovery.No additional reports have been received from this customer regarding the reported condition.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: no additional reports have been received from this customer regarding the reported condition.Root cause: user interface- user's interaction with the vista software.

Event Description

(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: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3828132
• MDR Text Key: 4393168
• Report Number: 1722028-2014-00190
• 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,Followup,Followup
• Report Date: 04/27/2014

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: 000000000000081000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2014
• Initial Date FDA Received: 05/22/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/16/2014; 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR