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

Model Number	2110
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: updated as first of june 2026, as the event date is unknown.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 cracks in the membrane of the infusion pump were identified during inspection.There was no patient involvement and no patient harm.

• Brand Name: CADD SOLIS HPCA 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: 25815190
• Report Number: 3012307300-2026-07415
• Device Sequence Number: 10602210
• Product Code: MEA
• UDI-Device Identifier: 15019517155006
• UDI-Public: (01)15019517155006(11)230125
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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: 21-2112-0402-51L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown