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

Catalog Number	21-0270-25
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection, functional testing, and event history log (ehl) review, the customer problem was duplicated.The alternating current (ac) plug was confirmed to have a cover on the body connection side of the plug that had come off and was damaged.The manufacturer representative replaced the ac adapter plug.
Event or Problem Description
The customer returned the product for a defective alternating current (ac) adapter, and during inspection it was found that the ac adapter cover on the body connection side of the plug had come off and was damaged.After investigation the results indicated a reportable malfunction due to the damage on the ac adapter.The event occurred during unpacking at facility, and there was no patient involvement.

• Brand Name: AC ADAPTER CADD SOLIS
• 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: 22284391
• Report Number: 3012307300-2025-07261
• Device Sequence Number: 8929571
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• 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: 06/18/2025
• 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: Initial
• 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