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

Catalog Number	21-6400-51
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: one device was received for analysis.Service history review found no similar complaints in the last 12 months.A complete accuracy test was performed and no faults were identified.The device passed all functional testing thereafter.
Event or Problem Description
It was reported that that the device had incorrect volume delivered in continuous mode requires calibration.There was unknown reported patient involvement.

• 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: 24912118
• Report Number: 3012307300-2026-03898
• Device Sequence Number: 9828178
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: (01)10610586019548(11)210422
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: Lay User/Patient
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/17/2026
• 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