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

Model Number 81000

Device Problems Use of Incorrect Control/Treatment Settings (1126); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.The signals in the rdf indicate that the trima system operated as intended.Fifteen percent (15%) of the donor's actual tbv (6853ml) is 1027 ml.The total volume taken from the donor was calculated at 502ml, <15% of the donor's tbv.The anticoagulant (ac) infusion rate that was used with the incorrectly entered donor height was 0.74ml/min/l tbv, below the safety threshold of 1.2ml/min/l tbv.The customer was made aware of the potential safety impact for the donor that entering incorrect donor data can have.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an incident of data input error in the trima system.The customer entered the donor's height as (b)(6) when the actual height is (b)(6).No medical intervention was required for this event.Per the customer, the donor was 'fine' after his donation.Donor (patient) full (b)(6).

Manufacturer Narrative

Investigation: a one year review of the devices service history was completed and no issues related to the reported condition where identified.Root cause: the root cause of this failure was user interface for the incorrect donor information entry and the root cause for the product volume issue was undetermined.

Manufacturer Narrative

This report is being filed to provide additional information and to correct donor unit # (b)(6) and root cause.Corrected root cause: the root cause of this failure was user interface for the incorrectdonor information entrycorrective action: an internal capa has been initiated to address the user interface issue ofdata entry errors.

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: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5274523
• MDR Text Key: 33441123
• Report Number: 1722028-2015-00641
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040069
• 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: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• 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
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2008
• 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: 65 YR
• Patient Weight: 109