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

Model Number 1400

Device Problems No Audible Alarm (1019); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Review of the event history log showed occurrences of a high pressure alarm, alarm complete, pump turned on, power lost while pump was on and alarm cancelled.Functional testing involved three separate accuracy tests and found the pump to within manufacturing specification of +/- 6%.No problems were found with the fluid delivery of the pump.The pump was run with low reservoir volume to test the pump's alarm issue and no problems were identified.The expulsor was replaced as a preventive measure.The downstream occlusion sensor was replaced and software applications were reinstalled.Based on the investigation, the complaint allegation was not confirmed.

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump was not administering the drug correctly and the alarm was not working.Per reporter, no additional information was available.No adverse patient effects were reported.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11348303
• MDR Text Key: 232540347
• Report Number: 3012307300-2021-01362
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 21-1401-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1