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

Model Number	21-7106-24
Health Effect - Clinical Codes	Vomiting (2144); Hot Flashes/Flushes (2153); Diaphoresis (2452)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The rn exchanged the cartridge containing remodulin and attached a new cadd [continuous ambulatory delivery device] extension tubing for delivery of the medication to the patient.Within approximately 30 minutes, the patient was experiencing a new onset of symptoms related to remodulin (vomiting, flushing, diaphoresis).The remodulin infusion was stopped, the physician was notified and orders received for treatment of symptoms.A new cartridge and tubing was obtained prior to restarting the infusion.

• 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: 25761444
• Report Number: 25761444
• Device Sequence Number: 16086373
• 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?: No
• 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: 46 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2026