MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-SOLIS, ADAPTER, AC, WALLWART, AMBULATORY ACCESSORIES; PUMP, INFUSION

Catalog Number	21-0270-25
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the customer reported issue of ¿the battery compartment was damaged¿ could not be confirmed, no signs or smells of burning could be observed.The alternating current (ac) adapter did not work when connected to mains.A history review is not applicable as the product is a supplied item.No action taken, the item is a purchased finished good (pfg) and will be scrapped.
Event or Problem Description
It was reported that there was a strong burn smell was coming from device.The faulty power supply was removed from service.There was no patient involvement, and no patient harm/adverse event reported.

• Brand Name: CADD-SOLIS, ADAPTER, AC, WALLWART, AMBULATORY ACCESSORIES
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22311674
• Report Number: 3012307300-2025-07534
• Device Sequence Number: 8794214
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884(17)310208(10)2107
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: 21-0270-25
• Device Lot Number: 2107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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