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

Model Number	2110
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 and h6 ¿ updated.One suspected device was received for evaluation.The event history log (ehl) was reviewed.No errors found in event log.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.No discrepancies related to the complaint were found during visual inspection.Communication module error was observed through power up test with signs of coin cell battery depletion when not holding time or date.The customer complaint was confirmed.Replaced printed circuit board assembly (pcba)/printed wiring assembly (pwa), performed downstream occlusion (dso)/ upstream occlusion (uso) sensor calibration, performed testing, unit passed all testing criteria.Software updated.Unit reset to standard configuration.
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 device displayed a communication module error during self-test.There was no patient involvement.

• 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 ; 2247062300
• MDR Report Key: 25285112
• Report Number: 3012307300-2026-05395
• Device Sequence Number: 9677473
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: (01)10610586038778(11)170619
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: Other
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown