MAUDE Adverse Event Report: ICU MEDICAL, INC. MEDEX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	TF55
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Utilizing a trifuse attached to the central line to increase access for multiple drips.Bedside nurse observed that the patient's blood pressure dropped.Bedside nurse immediately assessed the patient and found the bed to be wet.Bedside nurse realized trifuse had malfunctioned.Trifuse was removed it, drips restarted and monitored while the patient recovered.

• Brand Name: MEDEX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 23050590
• Report Number: 23050590
• Device Sequence Number: 9769182
• Product Code: FPA
• UDI-Device Identifier: 10351688500311
• UDI-Public: (01)10351688500311(17)27111(10)6068411
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/15/2025
• Report Date (Section F): 08/15/2025

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
• Device Model Number: TF55
• Device Lot Number: 6068411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/15/2025