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

Model Number AX1000

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2019

Event Type  malfunction  

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 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.

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¿
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 8955182
• MDR Text Key: 158637373
• Report Number: 1641965-2019-00013
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• 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
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1