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

Model Number	2110
Medical Device Problem Codes	Crack (1135); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported pump had downstream occlusion membrane damage.This event occurred during preventive maintenance.Photo samples was provided, which demonstrated the seal was compromised.There was no patient involvement and no harm.
Additional Manufacturer Narrative
It was reported pump had downstream occlusion membrane damage.This event occurred during preventive maintenance.Photo samples was provided, which demonstrated the seal was compromised.There was no patient involvement and no harm.
Additional Manufacturer Narrative
H6 - adverse event problem -medical device problem code was updated.The suspect pump was returned for evaluation.The event history log was reviewed, and no alarms related to the complaint were identified.No service history was recorded within the past 12 months.A visual inspection and functional testing were performed, revealing a cracked dso seal and a missing battery door and 46011 error code which is related to coin cell battery.The complaint was confirmed.The probable root cause was identified as a cracked dso seal.The dso seal requires replacement due to crack.

• Brand Name: CADD SOLIS HPCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24757899
• Report Number: 3012307300-2026-03184
• Device Sequence Number: 9101119
• Product Code: MEA
• UDI-Device Identifier: 15019517154986
• UDI-Public: (01)15019517154986(11)230315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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 Model Number: 2110
• Device Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown