MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-LEGACY ONE AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number	6400
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6: the suspected device was returned for analysis.No issues were found in the event history log (ehl).Service history identified that no previous repair has been noted in the past 12 months.The device was visually inspected.A functional test was performed, and the reported issue was confirmed through downstream occlusion test.Further investigation, the downstream occlusion (dso) sensor was found to be defective was noted.The cause of the reported issue was due to dso sensor defective.As a result, the dso sensor was replaced.The device passed all functional testing after repair.
Event or Problem Description
The customer was reported that the device had an event of constant beeping during testing.There was no patient involvement/ no harm reported.Evaluation of the returned device identified the defective downstream occlusion (dso) sensor which may lead to interruption of medication during use.

• Brand Name: CADD-LEGACY ONE AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25069790
• Report Number: 3012307300-2026-04526
• Device Sequence Number: 10425190
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: (01)10610586019548(11)190703
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K982838
• 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
• Report Date (Section B): 05/04/2026

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 Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown