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

Catalog Number	363904
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One picture of a used sample was provided for evaluation.The provided picture was visually evaluated; it was noted the set had been used and air bubbles were spotted in the picture.The defect is confirmed.A possible root cause of air in line alarms could be related to an incomplete priming of the iv line, infusion of cold solutions which may exhibit air bubbles coming out of solution as the fluid warms, or incomplete filling of the drip chamber during priming.Because a lot number was not provided it is not possible to determine if this device met the specifications that applied at the time it was manufactured.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
Additional information provided: according to the complainant, a 6-hour protamine infusion was being administered.The fluid was at room temperature, with the drip chamber ½ to 2/3 filled, and the tubing properly loaded.The intravenous (iv) line was primed through the pump, with the prime function being used to remove air from the line.During the infusion, an air in line alarm was triggered, prompting the following troubleshooting steps.The user reprimed the line, opened the pump door, removed and visualized the tubing, and then tapped the section in question to check for air bubbles.Air bubbles were visible.The user then wiped the tubing segment with an alcohol pad, specifically in the area between the silicone pump segment and the green clamp, before reloading the tubing and restarting the pump.The alarm recurred, prompting replacement of the iv set.One hour before completing the total 6-hour dose, an air bubble alarm was triggered again.The user attempted to flick the bubbles, but this method was ineffective.Additionally, the user felt that flushing the line was not as option, as it would result in lost medication, preventing the patient from receiving the full dose.The iv set was changed, and then the infusion was continued, with the last hour completed without any further issues.Please note, this event is being reported as "event 2." "event 1" was reported via report number 2523676-2025-00016.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21588493
• Report Number: 2523676-2025-00266
• Device Sequence Number: 18332203
• Product Code: FPA
• UDI-Device Identifier: 04046964699061
• UDI-Public: (01)04046964699061
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: 363904
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• 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