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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the patient's pump was leaking from the connector and there was white power on the pump and bag.They were instructed to put the pump in a chemo spill bag.The pump was powered off, clamp tubing, and they were educated on chemo spill protocol.The medication used was 5fu.The leak for this time and the previous leak occurred at the same place where the extension set and swivel piece were connected.Both leaks have been shared with them.There was patient involvement and no harm/adverse event reported.

• 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: 24521408
• Report Number: 3012307300-2026-02094
• Device Sequence Number: 21271976
• Product Code: FPA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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: 21-7047-24
• Device Lot Number: 6116712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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: 5FU, UNK MFR.; CADD PUMP, ICU MEDICAL.; CASSETTE, ICU MEDICAL.; EQUASHIELD SWIVEL.
• Patient Sex: Unknown