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

Model Number 1400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Fatigue (1849)

Event Type  malfunction  

Event Description

Information was received indicating that a patient was restarted on duopa using a smiths medical cadd-legacy duodopa ambulatory infusion pump after a new j peg had been inserted and had been off medication for one day.It was reported that "he became more tired since restarting duopa," and the patient's daughter had concerns the patient may have been getting too much duopa.Per reporter the "pump settings reviewed.All settings, continuous and morning dose, were decreased based on what is on file." per reporter the daughter subsequently inquired "if it ok to leave patient off of medicine for one day to see if symptoms improve and use oral medicine instead.Advised that this was okay, but to contact md to discuss." per reporter the daughter is working with the md concerning adjusting doses.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada ave. n.; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn ; 3833310
• MDR Report Key: 10220654
• MDR Text Key: 197211350
• Report Number: 3012307300-2020-06429
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N203952
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• 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