MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7002-24
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
It was reported that the device exhibited a disconnection below the port.There was patient involvement, no injury was reported.
Additional Manufacturer Narrative
H6: code were updated.One device was returned for investigation.An occlusion alarm was confirmed, with no flow detected between the pump and the patient.Dimensional analysis showed that both the male and female luer connections met manufacturing specifications.Although the reported issue of tubing disconnection below the port could not be verified, an occlusion was observed at the filter inlet of the extension set.Probable cause, excess solvent during assembly.No physical damage or other anomalies were found during the inspection.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CADD CASSETTE RESERVOIRS - NON FLOW STOP
• 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: 23066735
• Report Number: 3012307300-2025-10720
• Device Sequence Number: 21328945
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: (01)10610586022128(17)300114(10)6085507
• 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): 11/10/2025

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: Lay User/Patient
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 6085507
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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