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

Catalog Number	21-0270-25
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: one ac power adapter was received for evaluation in used condition.Physical evaluation showed the device was in used condition.Functional testing was performed, and the reported issue was confirmed.The ac power adapter did not charge due to damage observed on the loose metal contacts.It has been determined that the ac adapter duck head is coming apart, potentially exposing the metal contacts while still plugged into the wall outlet.The ac power adapter is a purchased finished good and will be scrapped.A device history review was not performed as the product is a supplied item.
Event or Problem Description
It was reported that the ac adaptor was not charging the device, and that there appeared to have been some arcing or burning occurring and melting of contacts.There was no patient involvement.

• Brand Name: WALLWART CADD-SOLIS AC ADAPTER
• 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: 22962801
• Report Number: 3012307300-2025-10320
• Device Sequence Number: 9515091
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884(17)330827(10)2324
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: 2324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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