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

Model Number 1400

Device Problem Infusion or Flow Problem (2964)

Patient Problems Dyspnea (1816); Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

Information was received indicating that a patient using a smiths medical cadd-legacy duodopa ambulatory infusion pump was struggling to breathe, could not move, had cramps and was in "bad agony." it was reported that "no medication was going through." patient was reported to have tripped on the top step of a stairs and had a fall which may have jarred the tube.Per reporter an ambulance was called and patient was taken to hospital.Follow up has been made for additional information regarding the details necessitating the ambulance and if the pump was a contributing factor.

Manufacturer Narrative

Device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Visual inspection showed entire device was worn, rear housing damaged and fluid ingression on the downstream occlusion sensor.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.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.Please disregard the initial report submitted with the mfr number: 3012307300-2021-03555.The report was submitted in error., corrected data: corrected information provided in h10.

• 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): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11742287
• MDR Text Key: 247900015
• Report Number: 3012307300-2021-03555
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1