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

Model Number	2110
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
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 cadd pump should have alarmed, but it did not alarm when there was no fluid in the line.The medication bag was not fully spiked into the epidural administration set.One cadd epidural pump was involved in the patient event, and another unit was obtained for testing.The nurse, along with the anesthesiology department, was able to duplicate the original problem using the second unit.During the procedure, despite the bag being only partially spiked, the unit continued to pump as if fluid was flowing through the line.The air-in-line alarm did not occur.Due to the device not alarming, the patient was rushed into emergency surgery to prevent further pain.The nurse who was present during the procedure was able to reproduce the issue using the same epidural setup.There was patient involvement, and the event resulted in patient harm.

• Brand Name: CADD-SOLIS HPCA PIB 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: 25691315
• Report Number: 3012307300-2026-06792
• Device Sequence Number: 9720610
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: (01)10610586038808(11)150717
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown