MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V NRFIT CADD 100ML EPID CASSETTES; SET, IV, FLUID TRANSFER

Model Number	7600
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was leakage inside the cassette.The event occurred during priming and there was no patient involvement.
Additional Manufacturer Narrative
B3: march 2026 was the reported month and year of the event, but the exact day was not provided.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.
Additional Manufacturer Narrative
D3 - manufacturing plant address 2: updated d3 - postal code: updated one used suspect product was returned for evaluation.Visual inspection was performed and was confirmed that there were no anomalies noted.Leak test was performed using a hydrostatic pressure pump and was observed that there was a leakage at the tube luer junction of each cassette during the ramp up.The cassette's tube and bond were separated, the tube and bond pocket were inspected and was found that there was a solvent channel on the tube.The allegation made by the complainant was confirmed due to the leakage observed at luer tube bond.

• Brand Name: NRFIT CADD 100ML EPID CASSETTES
• Common Device Name: SET, IV, FLUID TRANSFER
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; industrial internacional; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24758625
• Report Number: 3012307300-2026-03195
• Device Sequence Number: 8772401
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: (01)10610586044007(17)270501(10)6101906
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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 Model Number: 7600
• Device Catalogue Number: 21-7600-24
• Device Lot Number: 6101906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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
• Patient Sex: Unknown