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

Model Number	AX1000
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs and the compounding activity report (car) have been received.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As per user facility: customer reported issues with incorrect order volumes on the compounding activity report from one of the orders compounded.The order volume, delivered volume, expected weight and total delivered volume of individual ingredients are incorrect.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs and the compounding activity report (car) have been received and reviewed.This is a known software issue.The software issue has to do with scanning the source line barcode from the main screen to bring up the "replace container" screen for the current universal ingredient (ui).When this is done in the middle of an order (only possible if user first presses "pause"), then the universal ingredient will revert from whatever station it was (2 or 3) to station 1.The final flush of the order will be performed with sterile water from station 1 instead of the intended universal ingredient.This will result in less volume of the intended universal ingredient in the amount of the flush volume and more of station 1 (water) than intended in the amount of the flush volume.Some of this flush volume will not make it into the final container, as it will be used to fill the manifold for the next order.Also, a manifold flush will be required prior to that next order.Additionally, the compounding activity report will show incorrect values for both delivered volume and ordered volume, neither will reflect the intended ordered volume.There is an active apex software project to address this issue.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 75006 6690
• MDR Report Key: 8955182
• Report Number: 1641965-2019-00013
• Device Sequence Number: 2559805
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)04046955048502
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/29/2019

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: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1