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

Model Number 917000000

Device Problems Use of Device Problem (1670); Inadequate User Interface (2958); Patient Data Problem (3197)

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

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: with the donor's tbv of 7010ml, the donor would have qualified for the collection procedure that was completed.A terumo bct's system engineer performed a calculation for the potential ac overinfusion and hypovolemia for this event.The calculated ac infusion rate for both the entered and correct patient data are less than the maximum allowed ac infusion rate per the version 6.0 trima accel system administrator¿s guide.Therefore, it is unlikely that an ac overinfusion occurred due to the incorrectly entered donor information.Based on the trimaaccel automated blood collection system administrator's guide, the total volume removed from the male donor for both the entered and correct patient data resulted in less than 15% tbv being removed.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 for a collection procedure.The operator entered the incorrect donor's weight as (b)(6) when the actual donor weight was (b)(6).The vista software system calculated the total blood volume with the incorrect weight as 8470ml instead of the donor's actual total blood volume of 7010ml.The donor is reported in healthy condition.Patient (donor) full identifier: (b)(6).The customer declined to provide patient (donor) age.

Manufacturer Narrative

Investigation: terumo bct has followed up with this customer to provide feedback on the reported condition.It was determined that the ac infusion rate did not exceed the trima safety limit for the event.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no issues related to the reported condition identified.Root cause: user interface issue.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6857922
• MDR Text Key: 86279793
• Report Number: 1722028-2017-00372
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK010006
• 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
• Report Date: 09/12/2017

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: 917000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 120