MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD-SOLIS WIRELESS COMMUNICATION 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	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 : possible lot # 12798149.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 had a wireless module intermittent connection issue.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4: corrected.D9: product received date 11/8/2024.H3: one device was returned for analysis with complaint of wireless module intermittent connection issues.A dhr review is not applicable in this case because item is a purchased finished good, manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.Complaint that the device has wireless module intermittent connection issues could not be duplicated.Evaluation found the comm module connecting to the pump properly and was being detected without errors when paired with a known good operating pump.Testing did find the comm module failing to enable its wireless settings and connect to the wireless network.The most probable cause is a malfunctioning wireless radio board.Comm module is being sent to supplier for further analysis.

• Brand Name: CADD-SOLIS WIRELESS COMMUNICATION 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: 20544196
• Report Number: 3012307300-2024-12128
• Device Sequence Number: 15407933
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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 Catalogue Number: 21-2131-25
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown