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

Model Number 1400

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Shaking/Tremors (2515)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

Information was received indicating that a patient using a smiths medical cadd-legacy duodopa ambulatory infusion pump could not reduce the extra dose because the arrow key on the pump was "blocking." it was reported that patient had a "strong tremor and would like to reduce the extra dose from 0.5 to 0.4 ml.Per reporter the patient restarted the pump and was able to subsequently adjust the extra dose to 0.4 ml.

Manufacturer Narrative

Additional information was received indicating patient details, updated a2, a3.Per reporter: other relevant history, including pre-existing conditions: known depression, trauma patient, and abuse syndrome.

Manufacturer Narrative

Device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Visual inspection showed the entire device was used and the lock was worn.The investigation found no problems with the operation of the pump's keys or keypad.Additionally no reports of "key stuck" messages were found in the event history log.The pump was found to be operating properly and passed all tests.

• 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: 11038192
• MDR Text Key: 222367247
• Report Number: 3012307300-2020-12546
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 21-1400-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR