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 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device logs 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 there was a discrepancy between the ingredient pumping and the status on the control panel.The apex compounder was pumping dextrose from line 3 but the control panel was showing that water on line 1 was currently pumping.The bag was scrapped.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs have been received and reviewed.This issue has been identified as a software anomaly in the apex control module.Specifically, if the user sets up the compounder with an "electronic y" dispensing ingredient a and a second, adjacent "electronic y' dispensing ingredient b and the user attempts to change the adjacent ingredient b line to a compatible drug with a different drug name, the system associates the ingredient b line as part of the "electronic y' for ingredient a.This leads to situations in which ingredient b is dispensed in place of the intended volume of ingredient a.There is an active apex software project to address this issue.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As per user facility: customer reported there was a discrepancy between the ingredient pumping and the status on the control panel.The apex compounder was pumping dextrose from line 3 but the control panel was showing that water on line 1 was currently pumping.The bag was scrapped.No patient involvement.

• 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: 8508405
• MDR Text Key: 141750757
• Report Number: 1641965-2019-00009
• 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: 05/28/2019

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
• Device Operator: Health Professional
• Device Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1