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

Catalog Number	21-2131-01
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot#: possible lot number: 19081296.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 wireless module has an issue.The customer switched to another module and found that the wireless connection drops.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4: lot number; 19081296.D9: date returned to mfg; 2/11/2025.One device was returned for device analysis.Visual inspection and functional testing performed during analysis.The customer reported problem could not be duplicated or confirmed the failure during the investigation.No problem was found with the wireless connectivity functions of the returned device.

• 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: 21001511
• Report Number: 3012307300-2024-15342
• Device Sequence Number: 9867199
• Product Code: MRZ
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864(17)250114(10)19081296
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 21-2131-01
• Device Lot Number: 19081296
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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