MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. - APEX APEX®; APEX, SCDM CONTROL MODULE, WIN-10

Catalog Number	601237
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical 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: health professional team noticed that there have been a handful of orders being pumped at bbmus # (b)(4) that are having a discrepancy of exactly 13mls for line 1 (sterile water) of what is ordered and what is pumped.Health professional was informed that an error occurred on that pump a little after lunch (1pm) that caused them to restart the pump.The time stamps of some impacted bags are 2:34pm and 3:08pm.
Additional Manufacturer Narrative
This complaint has been identified as b braun medical internal complaint number (b)(4).The actual device involved in the reported incident was not returned for evaluation.The logs were provided for review.Prior to 12:59, the customer loaded a template overtop of a setup where there is a non-ui buffer of station 1 on the micro side (13 ml).That new template does not have the ui buffer, but it seems the user may not know this, since it seems to be withholding 13 ml from station 1 for a ui buffer that is never actually executed.The issue was replicated by the investigation team and the issue will be addressed in the upcoming software release.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: APEX®
• Common Device Name: APEX, SCDM CONTROL MODULE, WIN-10
• Manufacturer (Section D): B. BRAUN MEDICAL INC. - APEX; 1601 wallace drive; suite 150; carrollton TX 75006
• Manufacturer (Section G): B. BRAUN MEDICAL INC. - APEX; 1601 wallace drive; suite 150; carrollton TX 75006
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22461190
• Report Number: 2521402-2025-00155
• Device Sequence Number: 20835915
• Product Code: NEP
• UDI-Device Identifier: 04046955589524
• UDI-Public: (01)04046955589524(11)210525
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 Catalogue Number: 601237
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown