MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7047-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: no product was received for analysis.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that the device started leaking after they left.The pump was turned off.When they arrived, it would not turn on.The fluorouracil crystallized and even made its way inside the pump.The pump was removed from the cassette.No patient harm or no patient injury.The event occurred while in use with patient at patient's home.The operator of the device was a health professional.Associated cassette and pump complaints documented on (b)(4) and (b)(4).

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23498657
• Report Number: 3012307300-2025-12232
• Device Sequence Number: 13009937
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: (01)10610586023279(17)300414(10)6108390
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: 21-7047-24
• Device Lot Number: 6108390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown