MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Diana Cassette; set, administration, intravascular

Catalog Number	CH4000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved diana cassette assembly.It was reported that the liquid (5-fu) leaks from the system and crystallizes, despite several cassette replacements.Medication involved is 5-fluorouracil (5-fu).The status of the product at the time of the event was unknown.There was no patient involvement.
Additional Manufacturer Narrative
E1 - initial reporter phone is (b)(6).The device is not available for investigation.A supplemental mdr will be submitted if any updates become available.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: Diana Cassette
• Common Device Name: set, administration, intravascular
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. De R.L. De C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50944816
• Report Number: 9617594-2026-01371
• Device Sequence Number: 15836241
• Product Code: FPA
• UDI-Device Identifier: 00840619053222
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: BE
• PMA/510(K) Number: K080077
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: CH4000
• Device Lot Number: 14952030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown