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

Model Number	21-7106-24
Health Effect - Clinical Codes	Hearing Impairment (1881); Nausea (1970); Vomiting (2144); Diaphoresis (2452)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Shortly after the remodulin cartridge and cadd [continuous ambulatory delivery device] extension tubing was changed, the patient experienced severe symptoms of nausea, vomiting, flushing, diaphoresis, and clouded hearing.Infusion stopped, physician notified, treatment provided per physician orders.A new cassette was requested from pharmacy and new tubing applied.The patient did not experience any symptoms with the new cassette and new cadd tubing.No known harm at this time.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr; salt lake city UT 84123
• MDR Report Key: 25761442
• Report Number: 25761442
• Device Sequence Number: 18775900
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: (01)10610586023279
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/01/2026
• Report Date (Section F): 07/01/2026

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: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 6155153
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2026