MAUDE Adverse Event Report: HAMILTON MEDCIAL AG HAMILTON-H900

Catalog Number	950004
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2025
Type of Reportable Event	Death
Event or Problem Description
Infant was diagnosed with a bacterial infection pseudomonas aeruginosa.It was believed that the origin was from the hamilton h-900 due to the rain out.The h900 was later deemed not to be the source of the bacteria and was not liable.No cultures on product, testing was completed (context of testing is bioburden testing).

• Brand Name: HAMILTON-H900
• Common Device Name: HAMILTON-H900
• Manufacturer (Section D): HAMILTON MEDCIAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 21359268
• Report Number: 3016723884-2025-00003
• Device Sequence Number: 15573839
• Product Code: CBK
• UDI-Device Identifier: 07630002801546
• UDI-Public: 07630002801546
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2025
• Report Date (Section F): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 950004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/25/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/11/2025