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

Model Number 1400

Device Problems Infusion or Flow Problem (2964); Patient Device Interaction Problem (4001)

Patient Problems Tachycardia (2095); Shaking/Tremors (2515)

Event Type  malfunction  

Event Description

Information was received indicating that a patient was "concerned about the magnetic force of a" smiths medical cadd-legacy duodopa ambulatory infusion pump and was also "concerned over medication delivered." it was reported that during a "minor surgery" the patient's heartbeat "began to speed up and became shaky and body tremored." per reporter it was stated that the doctor "mentioned heart monitor tracking all over the place." it was also reported the patient became short of breath and was sent home.Additional information has been requested from the reporter regarding the issues that may have been experienced with the pump any if there was any relation of the pump to the surgery.No additional adverse 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada ave. n.; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn ; 3833310
• MDR Report Key: 9938402
• MDR Text Key: 187038770
• Report Number: 3012307300-2020-02871
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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
• Patient Outcome(s): Hospitalization