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

Model Number 1400

Device Problem Human-Device Interface Problem (2949)

Patient Problem Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

Information was received indicating that the setting values on a replacement smiths medical cadd-legacy duodopa ambulatory infusion pump were not updated, per reporter "it was forgotten." it was not indicated if the replacement pump was set to deliver more or less medication than the previous pump and this information has been requested from the reporter.Per reporter, the patient reported being akinetic five (5) weeks.It was reported that the replacement pump was subsequently programmed correctly.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was received indicating that a nurse helped the patient to program the replacement pump correctly.No information was received indicating that the product issue caused or contributed to patient or clinical injury.

Manufacturer Narrative

Device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.The investigation found that the pump was operating properly and passed all tests after service was completed.Based on the investigation, the complaint allegation was not confirmed.

• 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: 10092586
• MDR Text Key: 192200164
• Report Number: 3012307300-2020-05033
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1