MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7000
Medical Device Problem Codes	Complete Blockage (1094); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the extension sets were connected to the pump, it displayed "obstruction" not allowing to start the pump.There was patient involvement, but no patient injury reported.
Additional Manufacturer Narrative
H3: 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 reportable information becomes available.
Additional Manufacturer Narrative
One device has been received for evaluation.The evaluation is ongoing, and no results are available.If new information becomes available once the evaluation is complete a follow-up report will be submitted.
Additional Manufacturer Narrative
H2) device evaluation: d3 manufacturer establishment name updated.D9: 7/17/2025.H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, and the customer problem was not duplicated.The sample was received in non-used conditions.The samples were inspected visually, and defects were not found during the inspection.The samples were tested, and the sample was found acceptable with no occlusions were found during the inspection.The device passed all functional tests and performed as intended.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22292487
• Report Number: 3012307300-2025-07304
• Device Sequence Number: 8467000
• Product Code: FPA
• UDI-Device Identifier: 10610586020308
• UDI-Public: (01)10610586020308(17)291120(10)6070782
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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 Model Number: 7000
• Device Catalogue Number: 21-7046-24
• Device Lot Number: 6070782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/30/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/17/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Patient Sex: Unknown