MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. CADD SOLIS COMM MODULE SILEX 802.11; NEURAXIAL ADMINISTRATION SET - INTRATHECAL DELIVERY

Catalog Number	21-2131-25
Medical Device Problem Codes	Power Problem (3010); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.There were multiple common device names and corresponding pro-codes associated with this device.The additional names and codes are listed below: d2a.Common device name: set, administration, intravascular.D2b.Procode: fpa.D2a.Common device name: accessories, pump, infusion.D2b.Procode: mrz.D2a.Common device name: pump, infusion, pca.D2b.Procode: mea.D4.Primary udi number: the primary di# has been used as the expiration date is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.H4.Device mfg date: the reported lot# 12798149 could not be found for the reported catalog# 21-2131-25; therefore, the manufacturing date could not be determined.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 pump randomly had an issue with wireless connection and power.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
D9 date returned to mfg 1/27/2025.One device was received for analysis.Visual and functional testing was performed.The device was received in good condition.The reported event was not confirmed and could not be duplicated.Based on the evaluation results, no fault was found with the wireless connectivity functions of the comm module.

• Brand Name: CADD SOLIS COMM MODULE SILEX 802.11
• Common Device Name: NEURAXIAL ADMINISTRATION SET - INTRATHECAL DELIVERY
• Manufacturer (Section D): SMITH¿S 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: 21102986
• Report Number: 3012307300-2025-00411
• Device Sequence Number: 8656889
• Product Code: PYR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 12798149
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADD SOLIS HPCA PUMP KIT 2110
• Patient Sex: Unknown