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

Model Number 1400

Device Problem Infusion or Flow Problem (2964)

Patient Problem Ambulation Difficulties (2544)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump was delivering inconsistently.It was reported that there was an inconsistency "between the residual volume displayed by the pump and the quantity of duodopa contained in the cassette." per reporter the reservoir volume was reset every time a new cassette was placed and it was being set correctly.It was reported that the pump was subsequently exchanged.Other relevant history: tube change (b)(6) 2021, benign tumor left butt (b)(6) 2021, pilonal cyst operation (b)(6) 2020.Concomitant medical products reported as: patch neupro/clozapine.Per reporter the patient complained of blockage, but it was unknown if there was a link with the reported pump issue.No additional adverse effects were reported.Patient under duodopa since week of (b)(6) 2019.

Manufacturer Narrative

Other, other text: , corrected data: additional information was received indicating a correction to the original serial number reported.

Manufacturer Narrative

Device evaluation: one smiths medical cadd legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Visual inspection showed no damage to the pump.The customer's reported issue could not be duplicated.Investigation found no issues with the device delivering.The pump was tested and was found to be functioning properly and delivering within specification.

• Brand Name: CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
• Type of Device: INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11686442
• MDR Text Key: 246052961
• Report Number: 3012307300-2021-03272
• 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,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: 21-1400-02
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 90