MAUDE Adverse Event Report: ICU Medical Costa Rica Ltd. DianaTM Automated Drug Compounding System; System/device, pharmacy compounding

Catalog Number	CH5000
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: DianaTM Automated Drug Compounding System
• Common Device Name: System/device, pharmacy compounding
• Manufacturer (Section D): ICU Medical Costa Rica Ltd.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50045922
• Report Number: 9615050-2026-00800
• Device Sequence Number: 9481546
• Product Code: NEP
• UDI-Device Identifier: 00840619054908
• UDI-Public: (01)00840619054908
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AS
• PMA/510(K) Number: unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CH5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown