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

Model Number	2131
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the device was returned for root cause analysis.And the investigation findings concluded, after visual inspection, functional testing and event history log (ehl) review, the customer problem was not duplicated.The communication (comm) module was attached to its host pump.And the pole mount capture secured to the pump, powered the pump on to check battery status and the comm module operation having the alternating current (ac) adapter connected or not.Then removed, the pole mount capture from the back of the comm module.Configured the pump's wireless settings using the solis network setup utility, per established setup instructions to enable wireless communications.With the pump and the computer connected to the test wireless network (smtest5) and pinged, the pump to initiate data transfer.Kept the pump on idle state with the ac power adapter plugged overnight.No alarm occurred, even when powered on with the ac adapter plugged in.Nothing changed, when the pole mount capture was removed.The pump operated without failure and enabled wireless settings successfully using the latest version of solis network setup utility software to connect to the test wireless network.All data packets sent to the pump were transferred successfully with no loss registered.No connection errors or intermittent connection were observed, after multiple attempts to recreate the problem.No failure occurred, even after the pump was kept idle with the ac power adapter plugged in.The ehl confirmed, occurrence of the failure, but evaluation could not duplicate.The pump passed, all functional tests and performed as intended.D4, g4, h4: reported serial number (b)(6) is associated with a comm module device.However, the active device cannot be located in the system.And further information related to the primary udi number, manufacturing date and pma/510(k) number are unable to be obtained.
Event or Problem Description
It was reported, that the communication module was experiencing intermittent module connectivity alarm.The event occurred, upon opening at the hospital.There was no patient involvement.

• 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: 20858964
• Report Number: 3012307300-2024-14494
• Device Sequence Number: 18299642
• Product Code: MRZ
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: Other
• Device Model Number: 2131
• Device Catalogue Number: 21-2131-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 12/05/2024
• 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