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 Problem Cognitive Changes (2551)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Per reporter, there were two event dates of same reported issue, subsequent event documented on 3012307300-2020-11338.

Event Description

Information was received indicating that a patient did not disconnect themselves overnight from a smiths medical cadd-legacy duodopa ambulatory infusion pump and overdosed.Per reporter, the patient is "more burdened by hallucinations at the moment." it was also reported that the "patient forgets to disconnect the pump because he is currently more burdened by confusion.".

Manufacturer Narrative

Other, other text: additional information was received indicating the programmed pump settings were: md 8.0, cd 2.7ml, ed 2.0ml, ll0.The approximate volume that over-infused is unknown.No patient or clinical injury reported.Other relevant history, including pre-existing conditions: had a lot of hallucinations in the past.The event is ongoing.Patient information was received updated.

• 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
• MDR Report Key: 10823268
• MDR Text Key: 215896406
• Report Number: 3012307300-2020-11346
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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: 21-1400-06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR