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

Model Number	21-2130-51
Medical Device Problem Code	Application Security Problem (2882)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The food and drug administration notified smiths medical that the cadd-solis wireless communication module (wcm) could potentially be affected by a set of vulnerabilities identified in the cisa cybersecurity vulnerability notification (b)(4).The recently published advisory addresses multiple vulnerabilities affecting embedded tcp/ip software created by treck inc.This tcp/ip stack has been implemented in a wide range of industries and products, including the digi net+os operating system used in the cadd®-solis wireless communication module model 2130.Smiths medical has determined that the vulnerabilities identified in the advisory represent controlled risks to the affected cadd®-solis wireless communication devices as defined in fda guidance document postmarket management of cybersecurity in medical devices.The vulnerabilities found in digi net+os and treck tcp/ip stack are not specific or limited to smiths medical devices.There have been no customer reports of the vulnerability being exploited in the field.Smiths medical has received a patch from digi, the software vendor, and will release additional information on the issue and further actions as the same becomes available.

• Brand Name: CADD-SOLIS WIRELESS COMMUNICATION MODULE
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 10290804
• Report Number: 3012307300-2020-06843
• Device Sequence Number: 3462457
• Product Code: MEA
• UDI-Device Identifier: 10610586043628
• UDI-Public: 10610586043628
• Combination Product (Y/N): N
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: Other
• Device Model Number: 21-2130-51
• Device Catalogue Number: 21-2130-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1