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

Catalog Number 21-1400-51

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Chest Pain (1776); Shaking/Tremors (2515)

Event Type  malfunction  

Event Description

It was reported that a patient stated the caregiver pressed the extra dose button while setting up a cadd® cadd-legacy® duodopa pump.The patient received the morning dose and an extra dose.Patient stated one leg is shaking mildly and has "restless legs at night".Patient was advised to turn the pump off for 10 - 20 minutes and then switch back on if symptoms are resolved.Patient continues to display shaking of the legs and had chest pains during the night.Patient was advised to contact general practitioner.

• Brand Name: CADD® CADD-LEGACY® DUODOPA PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7810990
• MDR Text Key: 118093446
• Report Number: 3012307300-2018-03296
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-1400-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1