MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-SOLIS BATTERY PACK; PUMP, INFUSION, PCA

Model Number	2160
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 pump displayed ¿battery depleted.Pump will not run¿ alert and the alarm was sounding.Unable to proceed with pump set up.There was no patient involvement.
Additional Manufacturer Narrative
D3 - mfg establishment name: corrected.H3: the device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Visual and functional tests were performed.The customer's stated problem was not confirmed.There was no known cause of the reported issue, and item is a purchased finished good so it will be scrapped.

• Brand Name: CADD-SOLIS BATTERY PACK
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22137284
• Report Number: 3012307300-2025-06560
• Device Sequence Number: 15325200
• Product Code: MEA
• UDI-Device Identifier: 10610586031212
• UDI-Public: (01)10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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 Model Number: 2160
• Device Catalogue Number: 21-2160-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown