MAUDE Adverse Event Report: ST PAUL CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP; PUMP, INFUSION, ENTERAL

Model Number 1400

Device Problems Device Alarm System (1012); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problems Loss of Range of Motion (2032); Visual Disturbances (2140); Dyskinesia (2363)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump's continuous dose did not match the current prescription.It was unspecified if the does was higher or lower than the prescription and per reporter, no further information was available.It was also reported that the pump had frequent no disposable alarms and was "running slowly while delivering morning dose." it was reported that the patient experienced increased stiffness, increased difficulty moving, vivid/lucid dreams and increased hallucinations.No additional adverse effects were reported.

• Brand Name: CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10011870
• MDR Text Key: 189447255
• Report Number: 3012307300-2020-03540
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1401-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1