MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. APEX¿; SYSTEM/DEVICE, PHARMACY CO

Model Number	601223
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and 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: a patient order was compounded but the pump did not dispense any dextrose to the final container.It was stated that the patient order was completed successfully and declared in range by the software, yet the compounding activity report showed zero (0) dextrose was dispensed.The final container was scrapped.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The logs and a compounding activity report were provided for evaluation.From a log file review, apex plans to do the dextrose dispense as a manual addition.This means to complete the order the dextrose would have needed to be added manually.The order status would be "pending" until that was done.From the logs, it shows that at 11:46am, the user selected the option to always manually add this solution for dextrose.Once they do this, apex will automatically assign dextrose as a manual addition.The way to have the software forget the "always manually add" designation is to restart the software.In the next version of software, which is released and the end customer has plans to adopt, there is an "are you sure" message if the user checks the "always manually add" checkbox in the future.A follow up will be submitted when the investigation results become available.

• Brand Name: APEX¿
• Common Device Name: SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• Manufacturer (Section G): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12605310
• Report Number: 2523676-2021-00337
• Device Sequence Number: 19185843
• Product Code: NEP
• UDI-Device Identifier: 04046964801051
• UDI-Public: (01)04046964801051
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 601223
• Device Catalogue Number: 601223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown