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

Catalog Number	21-0270-25
Medical Device Problem Codes	Improper Flow or Infusion (2954); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the cadd pump lost power during patient-controlled analgesia administration.Per reporter, the loss of power was the result of battery depletion, as the pump was plugged in to charge, but the power adapter was defective and was not charging the device.The reporter did not indicate any alarm emitted from the pump to indicate the user of the battery depletion.The pump was replaced to resume infusion and the issue was resolved.
Additional Manufacturer Narrative
A1 and a4: updated.D1 and d4: updated.G4: updated.H3 and h6 codes: updated.D4: expiration date and h4: manufacture date is unknown; no information is available based on reported lot number.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD-SOLIS, ADAPTER, AC, WALLWART, AMBULATORY ACCESSORIES
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; minneapolis MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22795092
• Report Number: 3012307300-2025-09633
• Device Sequence Number: 12922512
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: Health Professional
• Device Catalogue Number: 21-0270-25
• Device Lot Number: 5323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DILAUDID
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White