MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-BC8022, BREATHING CIRCUIT SET

Model Number	260161
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4) initial report.
Event or Problem Description
Hamilton medical ag received the following incident description: "active humidification is installed and ventilation is started for a deeply sedated and ventilated patient with noradrenaline coming out of surgery.Subsequently, water leaks from the humidifier chamber, causing a continuous alarm on the ventilator; the entire ventilator had to be replaced, and the patient had to be bagged during this time in an unstable circulation situation".The issue did not result in any patient harm.Pending for breathing circuit set to be returned to hamilton medical for further investigation.The incident directly or indirectly led, might have led, or might lead to death or a serious deterioration in state of health of a patient, user, or other person.Therefore, this event is assessed as reportable.
Additional Manufacturer Narrative
Investigation outcome: an optical inspection of the parts was performed.The setup was complete, and no mechanical damage was observed on the tubes or the plastic part of the water chamber.Upon filling the chamber with water, the water spilled out at the front-right corner, recreating the issue reported in the complaint.To verify if other leak points existed, the chamber was sealed on one connector side, connected to a ventilator on the other, and subjected to an airflow of ~20 l/min.Air could only escape through the defective adhesive joint.No other leakage points were identified.Root cause: the investigation revealed a hole in the adhesive joint between the bottom plate and the chamber, causing the leakage.Each chamber undergoes a tightness test during production, applying 200 mbar and ensuring no more than 0.5 mbar pressure drop over 7.5 seconds.As this unit passed that test, the damage occurred post-production however, the root cause of the hole in the adhesive joint could not be reconstructed.Conclusion: the cause was identified as a hole in the adhesive joint that connects the bottom plate to the chamber.The supplier was informed about the issue.

• Brand Name: HAMILTON-BC8022, BREATHING CIRCUIT SET
• Common Device Name: HAMILTON-BC8022, BREATHING CIRCUIT SET
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz
• MDR Report Key: 22154340
• Report Number: 3001421318-2025-00646
• Device Sequence Number: 20704041
• Product Code: BZE
• UDI-Device Identifier: 07630002801560
• UDI-Public: (01)07630002801560(10)1900150138(11)250121(17)300120(240)260161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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 Model Number: 260161
• Device Catalogue Number: 260161
• Device Lot Number: 1900150138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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
• Patient Sex: Unknown