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); Data Problem (3196)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: (b)(4) support specialist performed a calculation on the approximate anti-coagulant (ac) infusion rate and determined that although the gender of the donor was incorrectly entered, the donor did not experience ac overinfusion or hypovolemia.It was calculated that the donor of the correct gender did not have less than 15% tbv removed during the procedure and the donor's ac infusion rate was lower than the maximum for the specified procedure time.The donor with the correct gender designation in the trima system is qualified to donate more concurrent platelet collection and rbc products.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 machine.A red blood cell(rbc) collection was being performed on a female, but the gender was entered as a male in the system.The customer stated that the patient (donor) is 'fine' and no adverse events occurred during or post-procedure.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.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 ac overinfusion 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.One year of service history was reviewed for this device with no similar issues 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: 6493676
• MDR Text Key: 73026155
• Report Number: 1722028-2017-00143
• 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
• Report Date: 04/14/2017

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: 03/20/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/02/2017; 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2001
• 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: 23 YR
• Patient Weight: 66