MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. CADD SOLIS HPCA PUMP; PUMP, INFUSION, PCA

Model Number	2110
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: customer reported complaint of ¿¿ remediation involves a software upgrade at no charge¿¿.Confirmed by performing pvt (performance verification testing), found software needs to be updated to latest version.Updated software to latest version.Upon further investigation found uso (upstream occlusion) seal is buckling.Replaced uso seal.Performed uso/dso (downstream occlusion) calibration.Performed pvt.Updated software.Unit passed all testing criteria.Unit reset to standard configuration.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
The following information was provided by the initial reporter: it was reported that the remediation involved a software upgrade at no charge.The event happened during preventive maintenance.There was no patient involvement, and no patient harm/adverse event reported.The following information was provided by the investigation: upon further investigation found uso (upstream occlusion) seal is buckling.

• Brand Name: CADD SOLIS HPCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22109434
• Report Number: 3012307300-2025-06369
• Device Sequence Number: 7201850
• Product Code: MEA
• UDI-Device Identifier: 15019517101003
• UDI-Public: (01)15019517101003(11)180307
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2018
• 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