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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the patient arrived with a leaking pump.They noticed it around 10 am and the bag had fluid in it.It was dry but the white residue was present on the pump and bag.They think that the leaking occurred somewhere between 9pm - 10am and they believe it was from the cassette tubing to tubing set connector.Spiros were added on the device between the port and the administration/extension set.No patient harm or no patient injury was reported.The event occurred while in use with patient at patient's home.The operator of the device was a health professional.Associated tubing and pump complaints documented on (b)(6).
Additional Manufacturer Narrative
One device was returned for analysis.Functional and visual tests were done, but the reported issue could not be duplicated.The cause of the issue could not be identified.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• 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.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23490963
• Report Number: 3012307300-2025-12203
• Device Sequence Number: 12918049
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: (01)10610586022128(17)300601(10)6116306
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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 Catalogue Number: 21-7002-24
• Device Lot Number: 6116306
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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