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

Model Number 1400

Device Problems Use of Device Problem (1670); Infusion or Flow Problem (2964)

Patient Problems Muscle Spasm(s) (1966); Nausea (1970); Anxiety (2328); No Information (3190)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

Information was received indicating that a patient using a smiths medical cadd-legacy duodopa ambulatory infusion pump was switching her pump on "too early in the morning" and receiving too much medication.It was reported that the patient was also doing "something wrong with the buttons" and receiving too much medication.It was reported that the patient was "not feeling well and is convinced that the dosages are incorrect and the pump isn't working well." per reporter the patient's evening dose had been increased and was supplemented by entacapone.It was reported that the pump was subsequently replaced.Per reporter no additional information was available and it was "not clear if there was anything wrong with the pump.".

Manufacturer Narrative

Other, additional information was received with patient details (age or date of birth, sex updated); adverse events updated.It was also reported that the patient was subsequently given an explanation about when the connect and disconnect the pump.

• 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: 11195236
• MDR Text Key: 227576630
• Report Number: 3012307300-2021-00568
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR