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

Model Number 1400

Device Problem Use of Device Problem (1670)

Patient Problems Anxiety (2328); Distress (2329); Dyskinesia (2363)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

Information was received indicating that a patient took oral night medication and fell asleep with their smiths medical cadd-legacy duodopa ambulatory infusion pump still attached.Per reporter the patient woke up with "serious dyskinesia and called emergency services in panic." it was reported that the ambulance nurse subsequently disconnected the pump.Patient was admitted to hospital for observation.It was reported that at the hospital it was discovered that the patient had several kidney stones and retention bladder and it was unknown if these were related to the product issue.Per reporter patient would not be treated for kidney stones.It was reported that 'patient is very neglected and most likely was messing around with pump settings and oral medication." no additional adverse effects were reported.

• Brand Name: CADD-LEGACY DUODOPA AMBULATORY INFUSION 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10968108
• MDR Text Key: 220209743
• Report Number: 3012307300-2020-12206
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR