MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7002-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device has not been returned to manufacturer.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 approximately 20 percent of the cassettes exhibited leakage of the filled preparation from the tubing outlet after filling.The clamp intended to ensure a tight seal was placed correctly and in the usual manner on the tubing.The leakage has been observed in production batches from winter 2025 through the present.The issue occurs during production, relatively soon after the cassette has been filled with the preparation and the clamp has been applied to the tubing, followed by disconnection of the coupling by the operator.Leakage may begin immediately or after a few seconds.The leakage rate has been observed to range from 7 to 19 percent, corresponding to approximately 20 to 50 units per batch; however, in some production batches, the number of cassettes leaking from the tubing has been lower.There was no patient involvement.

• Brand Name: CADD CASSETTE RESERVOIRS - NON FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4; parque industrial int; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25656200
• Report Number: 3012307300-2026-06605
• Device Sequence Number: 21269693
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: (01)10610586022128(17)291205(10)6077776
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K843772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: Other
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 6077776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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