MAUDE Adverse Event Report: B. BRAUN MEDICAL INC APEX; COMPOUNDER

Model Number AX1000

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: customer reported a bag was compounded and the compounder allowed a micro bubble of 8.71ml without requiring intervention from a pharmacist.The order was discarded and remade.There was no patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number 400466911.The logs were provided for investigation.The bubble threshold was set by the apex compounding system to be 0.30 ml.The bubble volume is recorded in the compounding activity report (car) as well as the "bubble events" window at the end of compounding.Review shows a bubble volume was reported as 8.71 ml, but the dispense was counted as successful, and there was no interruption to compounding or user alert.Investigation has identified this as a software bug.As mentioned, apex records every bubble that occurs on the car, even when they are not at the volume threshold where the system interrupts compounding and alerts the user.Apex interrupts and alerts when a bubble volume reaches 3% of the ordered volume for an ingredient, or in this case 0.30 ml.For this particular dispense, apex should have interrupted compounding and alerted the user.However, the volume of the bubble was still captured and recorded on the car (and the "bubble events" screen that the user can optionally see a the end of compounding).Apex project 20200211 was initiated to correct this issue in the next software update.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton, tx
• MDR Report Key: 9859390
• MDR Text Key: 190005333
• Report Number: 1641965-2020-00008
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: 04046955048502
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1