MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD DUODOPA PUMP 1400; PUMP, INFUSION, ENTERAL

Model Number 1400

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problems Fall (1848); Swelling (2091)

Event Type  malfunction  

Event Description

Information received a smiths medical cadd-legacy duodopa 1400 pump was infusing medication into stoma of a patients ostomy and wife reported patient has had a fall along with stoma was red and swollen.The family and caregiver reported stopping treatment due to the swelling around stoma and questioning if possibly getting to much medication.Over dose of medication can lead to complications as listed by abbvie website and are to be reported.Wife had also reported patient endured a fall.The medication is an aide to help control symptoms related to disease process but not a cure for parkinsons disease.The disease uncontrolled with out medication will exacerbate the symptoms of uncontrolled motor balance, tremor, coordination and may affect cognitive with memory.Wife has described treatment being stopped due to stoma issues and concern for over delivery.The fall is unknown if occured on medication or off.Skin irritation and redness can be treated and cured if seeking medical attention.Due to the concern for over delivery, this file is considered reportable, for medication in high doses can cause complications but mostly concerned with cardiovascular system and hypotension in high doses.

• Brand Name: CADD DUODOPA PUMP 1400
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, mn ; 3833310
• MDR Report Key: 9742720
• MDR Text Key: 180520574
• Report Number: 3012307300-2020-01612
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 01061058604303
• UDI-Public: 1061058604303
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1401-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• 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
• Patient Outcome(s): Other