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

Model Number 917000000

Device Problems Device Displays Incorrect Message (2591); Inadequate User Interface (2958); Data Problem (3196)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct's system engineer performed a calculation for the potential for 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 a cover infusion occurred due to the incorrectly entered donor information.Based on the trima accel 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 donor's weight as (b)(6) when the actual donor weight was (b)(6).The error was not discovered until approximately 23 minutes into the procedure.The operator ended the procedure with rinseback and disconnected the patient.No medical intervention was required for this event.Patient's (b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the trima disposable set used during the incorrect data entry error was returned for investigation.The rbc product bag was found attached and was dry of any fluid.The tubing set was visually evaluated for any misassembly, obstructions, leaks, or other defects with no anomalies found.Fluid was confirmed to flow freely throughout the disposable.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: a review of the device's service history was performed with no issues noted related to the reported condition.Terumo bct's clinical specialist provided feedback to the customer regarding the implications of incorrect data entry of donor information.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: an internal report indicates no further related issues have been reported for this device.Root cause: the root cause of this failure was the user entered the incorrect donor information.

• 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: 6671636
• MDR Text Key: 78704563
• Report Number: 1722028-2017-00266
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK990025
• 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,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2000
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 98