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

Model Number	2120
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
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 device air detector is loose and coming off.The issue was discovered during testing.There was no patient involvement.
Additional Manufacturer Narrative
One device was returned for analysis.Visual inspection found a delaminated downstream occlusion seal.Functional and visual tests were performed and the reported issues were duplicated.The cause of the reported issue was due to the air detector.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• 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: 20621057
• Report Number: 3012307300-2024-12779
• Device Sequence Number: 15672019
• Product Code: FRN
• UDI-Device Identifier: 10610586042836
• UDI-Public: (01)10610586042836(11)130326
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/27/2025

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: 2120
• Device Catalogue Number: 21-2120-0102-78
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2013
• 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