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

Catalog Number	490103
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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: during therapy patient iv pump with tpn alarmed "accumulated air exceeded." after pausing the drip and clamping the line, it was noted a small puddle of yellow liquid on the floor and the front/under side of the pump wet to the touch.After further assessment, the cassette was removed from the iv pole and found the tubing to be severed by the green clamp that gets inserted into the pump.Patient glucose was assessed at this time and new tubing was primed.
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 received sample was visually inspected and a cut was observed near the slide clamp, most likely caused by incorrect positioning of the set on the space pump.Based on the investigation finding, the reported defect was not confirmed to be due to the manufacturing process.The most probable root cause of cut tubing is believed to be attributed to mis-loading of the iv set into the space pump.It should be noted the infusomat space pump manuals, iv blister lids, insert cards, as well as the space pump clearly indicates the correct instructions for loading the iv set into the space pump.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
• MDR Report Key: 24188320
• Report Number: 2521402-2026-00023
• Device Sequence Number: 20806766
• 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): 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): 02/04/2026

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: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/04/2026
• 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