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

Catalog Number	21-2112-0300-01
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dso seal had been delaminated, and it had occurred during setup.There were no patient involvement and harm.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during visual inspection, which verified the reported condition of the downstream occlusion seal.Additionally, the investigation identified upstream occlusion seal damage.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The dso and uso seal was replaced and the device passed all testing.

• 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: 24272157
• Report Number: 3012307300-2026-00972
• Device Sequence Number: 13426527
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: (01)10610586038808(11)161212
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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 Catalogue Number: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown