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

Model Number	7046
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	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.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, once again there are occlusion issues, despite the equipment being intact, and after performing manual purging and replacing the pump, among other steps.The issue was resolved by switching to a different batch (cassettes and tubing).The reported issue was described as "purge impossible/occlusion", which occurred before use on the patient.There was no patient involvement.
Additional Manufacturer Narrative
H2) device evaluation: d3 manufacturer establishment name updated.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 device had no physical damage or anomalies observed.The used sample was leak tested at 45 pounds per square inch (psi) for 30 seconds using a hydrostatic pressure pump, and no leaks were observed.Then, in order to replicate clinical use, the extension set was connected to the returned cassette and 10ml of priming was performed on a pump, and no pump alarms were observed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22556604
• Report Number: 3012307300-2025-08637
• Device Sequence Number: 15862399
• Product Code: FPA
• UDI-Device Identifier: 10610586020308
• UDI-Public: (01)10610586020308(17)291216(10)6076058
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 7046
• Device Catalogue Number: 21-7046-24
• Device Lot Number: 6076058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2024
• 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