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 No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a patient manipulated a smiths medical cadd-legacy duodopa ambulatory infusion pump and subsequently their therapy was discontinued and patient was switched to oral medication.Per reporter, it was unknown if the "patient's manipulating of the pump caused an overdose of medication.".

Manufacturer Narrative

Other, other text: device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Visual inspection showed the pump was in good condition.The investigation found no issues with the device delivering, it was found to be functioning properly and delivering within specification.Review of the event history log showed the pump's programmed parameters were changed in late november and were subsequently changed back to the original programmed values.It is unknown who performed the changes.

Manufacturer Narrative

Other, other text: additional information was received indicating that the pump was not defective.

• 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: 11015668
• MDR Text Key: 221731750
• Report Number: 3012307300-2020-12444
• 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: 02/03/2021

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: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-03
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/05/2021; 02/01/2021
• Supplement Dates FDA Received: 01/15/2021; 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1