MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS COMM MODULE; ACCESSORIES, PUMP, INFUSION

Catalog Number	21-2131-25
Medical Device Problem Codes	Failure to Infuse (2340); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
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 there was an intermittent issue with both the bolus cord and wireless connectivity.Per reporter, the file was pushed twice, wi-fi module reseated, and a new bolus cord was tried, but the issue persisted.There was unknown patient involvement.No patient harm/adverse event was reported.
Additional Manufacturer Narrative
Received one device, evaluation could not duplicate the reported failure after all attempts testing the comm module on a known good solis pump worked as intended.

• Brand Name: CADD-SOLIS COMM MODULE
• Common Device Name: ACCESSORIES, 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: 21102839
• Report Number: 3012307300-2025-00405
• Device Sequence Number: 9105685
• Product Code: MRZ
• UDI-Device Identifier: 15019517171969
• UDI-Public: (01)15019517171969(17)250622(10)13628719
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Expiration Date: 06/22/2025
• Device Catalogue Number: 21-2131-25
• Device Lot Number: 13628719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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