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

Catalog Number	362033
Medical Device Problem Codes	Device Alarm System (1012); Air/Gas in Device (4062)
Health Effect - Clinical Code	Distress (2329)
Date of Event	05/21/2025
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: details of complaint (reported issue): back to back shifts as pt started tpn @ 1800 and infused overnight, there was consistent air bubbles and consistent alarms, trouble shooting techniques attempted, despite priming on the pump still had numerous air bubbles, as well as attempts to change the tubing numerous times and changing out the pump.Alarm events air in line - not visible and unresolved.Delay in pt receiving ordered amount of lipids for parenteral nutrition.Impact to patient: delay in treatment, emotional distress, interruptions to clinical care due to time required to resolve alarms, risk for infection / introduction of contaminants, under dosing of ordered medication / fluids.Action(s) taken changed out pump (isolate and send to bioengineering department), followed b braun tips to resolve alarms (air-in-line and occlusion), repeated priming to clear air, tubing replaced (triple bag and send to material management).Medication / fluid lipids iv rate approx 12ml.
Additional Manufacturer Narrative
This correction report has been submitted to clarify the following information: this report has been identified as a b.Braun internal report number (b)(4).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.The unit involved in the reported concern was never returned; however, a copy of an excel spreadsheet was submitted for evaluation.A proper investigation could not be performed from the evidence provided in the spreadsheet.Therefore, the issue reported 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.

• 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: 22382737
• Report Number: 2521402-2025-00203
• Device Sequence Number: 13025484
• Product Code: FPA
• UDI-Device Identifier: 04046964837821
• UDI-Public: (01)04046964837821(11)241018(17)270930(10)0061962577
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2025

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: 362033
• Device Lot Number: 0061962577
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/07/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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