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

Model Number 2110

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 unknown.One device was returned for analysis.Visual inspection showed a worn downstream occlusion sensor seal and a worn upstream occlusion sensor seal.The tamper seal was broken.There was no evidence to review in the device's event history log.A functional test was performed and the reported issue duplicated.The device powered in the downloading mode and could not boot up pass this screen.The manufacturing utility mode was accessed, and no software was present in the device.It was determined that the probable cause was due to a disruption to the usb connection during firmware installation.As a result, a functional testing was performed and passed.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.

Event Description

It was reported that the pump was stuck on the loading screen even after attaching to the computer and reinstalling the batteries.It is unknown if there was patient involvement, no adverse patient effects were reported.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18450082
• MDR Text Key: 332736824
• Report Number: 3012307300-2024-00093
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1