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

Catalog Number	490100
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Skin Discoloration (2074); Reduced Blood Flow (4598)
Date of Event	02/09/2026
Type of Reportable Event	Death
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 we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a 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.
Event or Problem Description
As reported via medsun number (b)(4): a neonatal patient experienced a serious adverse event during therapy involving an arterial line (a-line) and associated intravascular administration sets.A neonatal nurse practitioner (nnp) was called to the bedside to assess the patient's left arm, where mottling was observed throughout the arm, chest, and back, along with decreased perfusion to the hand.The arterial line was removed.Subsequent ultrasound examinations of the left upper extremity (lue) and head ultrasound (hus) identified a large amount of air emboli.The patient's clinical condition deteriorated, with worsening lactic acidosis following administration of medications and intubation.Repeat imaging, including hus, ct, and mri, demonstrated extensive brain injury.The event was considered life-threatening and resulted in death (reported february 2026).Although requested, additional information has not been made available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Retained units were evaluated and passed the internal testing.Since a sample was not returned for evaluation, the exact root cause of this incident could not be determined.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.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: 24741698
• Report Number: 2521402-2026-00295
• Device Sequence Number: 15110420
• Product Code: FPA
• UDI-Device Identifier: 04046955674992
• UDI-Public: (01)04046955674992(11)251105(17)281105(10)0062029379
• 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): 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): 03/31/2026

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: 490100
• Device Lot Number: 0062029379
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female