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

Catalog Number	490103
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample used without packaging was returned for evaluation.The sample provided was visually evaluated and was found to match catalog number 480264, not 490103.Upon evaluation, a disconnect between the pump segment and the tubing was confirmed.It is possible that insufficient solvent contributed to this issue.The defect reported was confirmed.Incidents of this nature are attributed to operator oversight during the manual solvent application process of the product.The operator applied insufficient solvent on the tubing during the bonding process.Although our training procedures ensure that our employees are properly trained in their areas of responsibility, an oversight on the operator's part can be attributed to an incident of this nature.All available information regarding this occurrence has been forwarded to the appropriate manufacturing business unit in order to heighten awareness.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: during therapy, a registered nurse (rn) was called to the patient's room due to excess air observed in the lipid tubing without a corresponding air in line alarm from the pump.The nurse clamped the lipid tubing and initiated replacement of the pump.Upon removing the lipid tubing from the pump, the tubing was observed to be sliced at the point of exit inside the pump, which allowed air to accumulate within the line.No injury reported.

• 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: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 25136307
• Report Number: 2521402-2026-00469
• Device Sequence Number: 21161129
• Product Code: FPA
• UDI-Device Identifier: 04046964302107
• UDI-Public: (01)04046964302107
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 490103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/11/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown