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

Model 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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: the device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Visual and functional tests were performed which found a depleted battery status and the comm module failed to enable the wireless settings of the pump and connect to the wireless network.The cause was suspected to be the wireless radio board.The comm module is being sent to supplier for further analysis.
Event or Problem Description
It was reported that the wireless communication module was not working (out of box).The results of the investigation found that there was a depleted battery status.There was no patient involvement, and no adverse event reported.

• Brand Name: CADD-SOLIS COMM MODULE
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20658571
• Report Number: 3012307300-2024-13115
• Device Sequence Number: 20675520
• Product Code: MRZ
• UDI-Device Identifier: 15019517171969
• UDI-Public: (01)15019517171969(17)240613(10)10343942
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: 21-2131-25
• Device Catalogue Number: 21-2131-25
• Device Lot Number: 10343942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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