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

Model Number	6400
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: the device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Visual and functional tests were performed.The customer's stated problem was not confirmed.The device was delivering within specification.There was no known cause of the reported issue, and no further action will be taken.
Event or Problem Description
It was reported that the device was delivering incorrect volume in continuous mode and it required calibration.There was unknown patient involvement and unknown patient harm.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25229961
• Report Number: 3012307300-2026-05205
• Device Sequence Number: 15998353
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: (01)10610586019548(11)210422
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown