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

Catalog Number	21-2131-25
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shows an error " wireless module intermittent connection with pump".There was no patient involvement.
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.The device has not been returned to the manufacturer.
Additional Manufacturer Narrative
Device was not returned for analysis for complaint that the device shows an error " wireless module intermittent connection with pump".However, photographic evidence in complaint file attachment shows the host pump failing with "wireless module intermittent connection with pump".With the comm module not physically received for evaluation, we are unable to determine a probable cause due to the intermittent nature of the failure based on prior internal investigation findings.

• Brand Name: CADD SOLIS COMM MODULE
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20802339
• Report Number: 3012307300-2024-14201
• Device Sequence Number: 13213126
• Product Code: MRZ
• UDI-Device Identifier: 15019517171969
• UDI-Public: (01)15019517171969
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Catalogue Number: 21-2131-25
• Device Lot Number: 19481649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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