MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. - BETHLEHEM INFUSOMAT®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	362035
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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: air bubbles noted.Action(s) taken changed out pump (isolate and send to bioengineering department), tubing replaced (triple bag and send to material management).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation, the root cause of the reported incident was unable to be determined.The reported defect was unable to be confirmed.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
According to the complainant, air bubbles were observed in the pump.Reportedly, the pump was creating turbulence causing air in line.Additional information was received which revealed that a significant amount of air bubbles were observed in the tubing without any beeping or alert for air bubbles.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Additional information received, section b5 has been updated.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC. - BETHLEHEM; 824 12th avenue; bethlehem, pa 18018 ; GM 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC. - BETHLEHEM; 824 12th avenue; bethlehem, pa 18018 ; GM 18018
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd.; allentown, PA 18109 ; 8334251464
• MDR Report Key: 23905214
• Report Number: 2521402-2025-01597
• Device Sequence Number: 9147918
• Product Code: FPA
• UDI-Device Identifier: 04046964699047
• UDI-Public: (01)04046964699047
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 362035
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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