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

Model Number	AX1000
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton, tx
• MDR Report Key: 9859390
• Report Number: 1641965-2020-00008
• Device Sequence Number: 3153810
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: 04046955048502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1