MAUDE Adverse Event Report: ICU Medical, Inc. Plum; Set, administration, intravascular

Model Number	1468728
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: Plum
• Common Device Name: Set, administration, intravascular
• Manufacturer (Section D): ICU Medical, Inc.; 600 n field dr.; lake forest IL 60045
• MDR Report Key: 50806245
• Report Number: 50806245
• Device Sequence Number: 20995932
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/26/2026
• Report Date (Section F): 08/26/2026

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: 1468728
• Device Catalogue Number: 1468728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• 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 Sex: Male
• Patient Weight: 165 LB
• Date Report Sent to FDA: 08/26/2026