MAUDE Adverse Event Report: B.Braun Melsungen AG Infusomat®; PUMP, INFUSION

Catalog Number	8713051U
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: failed to detect air bubble when used on patient.
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.

• Brand Name: Infusomat®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B.Braun Melsungen AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B.Braun Melsungen AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; +1(833)425-1464
• MDR Report Key: 50896171
• Report Number: 9610825-2026-00531
• Device Sequence Number: 5828848
• Product Code: FRN
• UDI-Device Identifier: 04046964660887
• UDI-Public: (01)04046964660887(11)240621(10)24202A5000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 8713051U
• Device Lot Number: 24202A5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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