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

Catalog Number	363421
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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: reason of complaint: infusomat line claimed to have pulled air into the pump while infusing a medication.This particular medication is a rescue drug given post high-dose chemotherapy to prevent hemorrhagic cystitis.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was provided for evaluation.The sample was visually evaluated, and no defects were observed.To replicate the reported defect of the air-in-line alarm on the pump, the sample was attached to the pump and then tested by running therapy while staggering the flow rate throughout the therapy.No alarms occurred during the testing of the returned sample.Thereafter, a functional leakage test was performed on the sample, and no leakage was detected.A measurement of the outer diameter of the pump segment tubing was taken and found to be 0.153inches, which meets the specification of 0.150-0.154inches.Based on the investigation findings, the sample met internal specification; therefore, the reported defect was not confirmed.Several factors related to air in line could contribute to inadequate priming of the iv-line, infusion of cold solutions which may exhibit air bubbles as the fluid warms up, incomplete filling of the drip chamber during priming, etc.Multiple complaints were reported against various items for air in line.A corrective action and preventive action (capa) was initiated to correct this issue and provide corrective action.Since a lot number was not provided, it is not possible to determine if this device met the specifications applied at the time it was manufactured.If the device was manufactured after the actions implemented under the capa, then the device is within specification.However, if the device was manufactured before the implementation of the actions taken within the capa, there is a potential the device is not within specification.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: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 23655862
• Report Number: 2521402-2025-01521
• Device Sequence Number: 4903280
• Product Code: FPA
• UDI-Device Identifier: 04046964294617
• UDI-Public: (01)04046964294617
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 363421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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