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

Catalog Number	362911
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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: describe the event or problem (please provide as much detail as possible): rn entered the room at 2030 to blina pump beeping air in line.This bubble was around 3 inches of tubing ling.This rn was able to flick the air bubbles out and restart the infusion.At 2045, the pump began alarming again.Upon inspecting the line this rn noticed that the air bubble was significantly large stretching from the cassette that clips into the pump to the valve/y-site above the pump.This rm notified the charge nurses, h2 pharmacy, and the practitioner.After many attempts to get rid of the air and switching the pump out, the decision was made to hang a new bag of blina.Unsure if this event was related to bbraun tubing/pump of curlin tubing (yellow tab of curlin broke off per dayshift rn).This rn hung the new bag of blina with another rn at 2109.Tubing and pump saved on cl office.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used contaminated sample and a video were provided for investigation.Upon evaluation of the iv set, it was noted that the iv set accompanying the 362911 set had a yellow clamp that impeded the flow.The sample was leak tested with no leakage detected.To replicate the air in line alarm, the sample was attached to the pump and tested by running therapy while varying the flow rate throughout.No alarms occurred during testing.The sample was occlusion test with passing results.The outer diameter of the pump segment tubing was measured and found to be within specification.The video noted that the user performed priming on the set with no alarms.The reported concern was not confirmed.A possible root cause could be related to incomplete priming of the iv-line, infusion of cold solutions which may exhibit air bubbles coming out of the solution as the fluid warms, incomplete filling of the drip chamber during priming.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 DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21741450
• Report Number: 2523676-2025-00322
• Device Sequence Number: 15650977
• Product Code: FPA
• UDI-Device Identifier: 04046964837845
• UDI-Public: (01)04046964837845
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 362911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/29/2025
• 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