MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT®; PUMP, INFUSION

Catalog Number	8713052U
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample, serial number, or device logs were provided.Further investigation of the complaint is not possible without a sample and/or device logs.The reported defect was unable to be confirmed.The actual defective device is valuable tool in investigating the cause of this incident.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: the pump was not successfully cleared of the precedex infusion which was previously programmed as a primary.It appears the nurse auto-programmed the lr bolus and it was assigned as a secondary on the pump since the precedex remained as the primary infusion.This also explains the error in the epic report - likely due to a primary/secondary channel mismatch since epic was unable to register a successful pump start via the primary channel.According to the dosetrac data, the lr was programmed as a secondary and infused for about 30 minutes before reverting to the primary precedex infusion (which is expected if the "back to prim" setting in the device is set to "automatic").
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Test result(s): [ ] defect confirmed [x] defect not confirmed.Results description: technical evaluation of the device did not identify any nonconformances or device performance problems which would directly contribute to the reported event.Device was sent for preventive maintenance.Active device history log review: [ ] n/a [ ] defect confirmed [x] defect not confirmed.Details of history log: log review shows infusion d5lr continued without interruption on 8/3/2025 at 19:58.Log also confirms expected pump shut-down due to depleted battery after infusion was complete and door opened.

• Brand Name: INFUSOMAT®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22888191
• Report Number: 9610825-2025-00510
• Device Sequence Number: 14687360
• Product Code: FRN
• UDI-Device Identifier: 04046964708626
• UDI-Public: (01)04046964708626(11)211101(10)97023111I1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142596
• 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): 09/04/2025

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: 8713052U
• Device Lot Number: 97023111I1
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown