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

Catalog Number	21-2111-0300-01
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
The pump generated an upstream occlusion alarm during infusion.The contents were removed from the bag, and no tubing kinks or closed clamps were found.An attempt was made to restart the pump; however, the device prompted the user to power it off.The battery door was opened for approximately 10 seconds, and the pump was powered back on, but the alarm persisted and again instructed the user to power off the device.This process was repeated multiple times, with the alarm continuing and repeated requests to power off.Subsequently, the keypad became locked.The event occurred in the patient's home during infusion.Patient involvement was reported; however, no patient harm resulted from the event.

• Brand Name: CADD-SOLIS HPCA AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 25732984
• Report Number: 3012307300-2026-07053
• Device Sequence Number: 18780148
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: (01)10610586038778(11)180718
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K130394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2018
• Is the Device Labeled for Single Use? (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-1667-1668-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown