MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-LEGACY DUODOPA; PUMP, INFUSION, ENTERAL

Model Number 1400

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Event Description

Information was received that the cadd legacy duodopa pump gets very warm and cannot be started.No reported adverse effects.

Manufacturer Narrative

One cadd duodopa pump was returned for analysis in used condition.Use testing was performed.The customer complaint was confirmed due to error 1720 on power up.Service replaced the backup capacitor.The root cause was the backup capacitor.

• Brand Name: CADD-LEGACY DUODOPA
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7615526
• MDR Text Key: 111836809
• Report Number: 3012307300-2018-02462
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-12
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1