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

Model Number 1401

Device Problems Inaccurate Delivery (2339); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd duodopa pump, the pump was not functioning correctly.It was reported that the patient experienced symptoms after first titration and believed that the pump was not delivering the right amount.Reported that the pump is still in use and the patient will follow up with the md about dosing.No additional adverse effects reported.

Manufacturer Narrative

H22: see d4, d5, h4 and h6 (conclusion code).

• Brand Name: CADD DUODOPA PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9537105
• MDR Text Key: 173386370
• Report Number: 3012307300-2019-07608
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1401
• Device Catalogue Number: 21-1401-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1