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	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: one device was received for evaluation.Service history review indicated no applicable history.A performance verification test (pvt) was performed; however, the initial customer issue of downstream occlusion" was not confirmed.The customer issue of ¿cover torn¿ was confirmed through visual inspection as the downstream occlusion (dso) seal was found to be cracked.The seal was replaced.Dso seal was calibrated and occluded at 23.3 psi.The upstream occlusion (uso) seal was replaced as a preventative measure.A performance verification test (pvt) was performed, and the device passed all testing criteria.Software was updated, and the device was reset to standard configuration.
Event or Problem Description
It was reported that the pump had a downstream occlusion and cover was torn.There was no patient involvement.

• 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: 24638493
• Report Number: 3012307300-2026-02680
• Device Sequence Number: 15932323
• Product Code: MEA
• UDI-Device Identifier: 15019517101003
• UDI-Public: (01)15019517101003(11)1169501
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 21-2112-0401-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown