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	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of inaccuracy could not be confirmed from the photo provided.Without the return of the sample a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved a diana cassette where the customer reported that the technical operator who was setting up the chemotherapies noticed that the quantity taken from diana (13 ml) does not correspond to what was set on the display (15 ml).When inspecting the syringe of the ch4000 in which a different volume of drug was apparently withdrawn, the operator noticed that the graduated marks are not at the same level between this ch4000 and those of another ch4000.The customer did a counter test the following day using physiological solution and aspirating it with another syringe and they noticed that the issue was with the ch4000 (aspirates two ml more than the liquid level on the syringe mark) and not on the diana equipment.The customer stated that one defective device was found.The prepared chemotherapy drugs were 5-fluorouracil.There was no physical defect on the cassette.The problem has not been encountered with certain specific drugs.There was no patient involvement.

• 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 ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21710844
• Report Number: 9617594-2025-00577
• Device Sequence Number: 18627294
• Product Code: FPA
• UDI-Device Identifier: 00840619053222
• UDI-Public: (01)00840619053222(17)270801(10)14096647
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 14096647
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5-FU CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown