MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS COMM 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	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that upon implementation, the pump had an out of box failure.With wireless intermittent connection with pump.There was no patient involvement.
Additional Manufacturer Narrative
One device was received, with the host cadd solis pump to be evaluated together.Evaluation found the failure occurring, when the comm module is tested on its host pump, with ac power adapter plugged in.And identified, the comm module was not fully latching inside its host pump.The failure occurred, with or without a pole mount capture mounted, but not repeating, when a known good test solis pump was swapped.Determined, the host pump was contributing to the failure.

• Brand Name: CADD-SOLIS COMM MODULE
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS 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: 20849909
• Report Number: 3012307300-2024-14419
• Device Sequence Number: 19765650
• Product Code: MRZ
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864(17)240605(10)18766925
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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 Catalogue Number: 21-2131-01
• Device Lot Number: 18766925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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