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

Catalog Number	21-0270-25
Medical Device Problem Code	Melted (1385)
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: no device or device photo was returned for investigation.Due to this, no root cause was determined as a product evaluation and problem confirmation cannot be performed.No previous repair has been noted as product is a supplied item, and no event log history is applicable.If the product is returned, this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that upon reviewing no charge with ac adaptor.Customer just wanted to bring to icu medical¿s attention an issue that they are starting to see with the cadd solis plug packs and noticed a few instances recently of contact issue with the plug adapter on the power pack.There seems to have been some arcing or, burning occurring and melting of contacts.There was no patient involvement.

• Brand Name: CADD-SOLIS AC ADAPTER
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22137308
• Report Number: 3012307300-2025-06561
• Device Sequence Number: 17981171
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0466-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown