MAUDE Adverse Event Report: ICU Medical, Inc CADD-Solis HPCA PIB Pump; Pump, Infusion, Pca

Model Number	2110
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction

• Brand Name: CADD-Solis HPCA PIB Pump
• Common Device Name: Pump, Infusion, Pca
• Manufacturer (Section D): ICU Medical, Inc; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 600 n field dr; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50744156
• Report Number: 3012307300-2026-08682
• Device Sequence Number: 8862072
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: (01)10610586038808(11)160516
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 21-2112-0300-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown