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

Model Number 1400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump may have over-delivered.Per reporter the patient had called an emergency line and during the subsequent visit from paramedic reported patient stated that he "felt like his pump was giving him too much medication." paramedic also reported the patient indicated that the pump "seemed to have rectified itself." it was also reported that the patient "felt like it was leaking" and patient subsequently disconnected the infusion.Per reporter the patient indicated that he was feeling "over medicated." no additional information was provided.

• 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: 10546183
• MDR Text Key: 207308328
• Report Number: 3012307300-2020-09422
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 21-1400-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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