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

Catalog Number	362035
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Distress (2329); Hemodynamic instability (4868)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: multiple and consistent air in line alarms throughout shift on lines running high dose norepinephrine, vasopressin, epinephrine, fentanyl, normal saline.Actual air in line present and having to be primed through or tapped out.Back up lines in place and being used but also developing air in line themselves.Due to patient's unstable condition and absolute reliance on these medications, requiring nurse at bedside at all times to troubleshoot alarms.Impact to patient: emotional distress, interruptions to clinical care due to time required to resolve alarms, vital signs compromised.Action(s) taken followed b braun tips to resolve alarms (air-in-line and occlusion), repeated priming to clear air.Medication / fluid norepinephrine.Iv rate 0.65 mcg/kg/min.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.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.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23038079
• Report Number: 2521402-2025-00859
• Device Sequence Number: 18655546
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: 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: 08/27/2025
• Initial Report FDA Received Date: 09/12/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown