MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number	2110
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: 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 reportable information becomes available.
Event or Problem Description
It was reported that the device was alarming with the screen message, "cassette not attached properly.Reattach cassette." this event occurred during testing.There was no patient involvement.
Additional Manufacturer Narrative
One device was returned for repair with complaint of cassette not attached properly alarm.No service record for the last 12 months.Review of event history found cassette not attached properly appeared intermittently over the past 3 months.Visual/functional testing was performed.Confirmed through the downstream occlusion (dso) test.Probable cause the dso sensor.Replaced dso sensor and seal.Performed downstream occlusion dso test and device passed.Upon further investigation, found battery compartment was damaged and was replaced along with all components within.The battery door contacts were damaged and replaced.Lcd lens was cracked and replaced.Lemo connector has a pin stuck in it and the board had burn damaged to that area, the printed wire assembly (pwa) board was replaced.Device passed all testing criteria post repair.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20385144
• Report Number: 3012307300-2024-10639
• Device Sequence Number: 17783692
• Product Code: MEA
• UDI-Device Identifier: 15019517084344
• UDI-Public: (01)15019517084344(11)170125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• 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,Followup
• Report Date (Section B): 01/06/2025

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: 21-2111-0300-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2017
• 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