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 Ambulation Difficulties (2544)

Event Date 06/21/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump may have over delivered medication.It was reported that the pump alarmed "reservoir volume not in use" and it "appeared that the cassette was empty." per reporter the patient was one (1) hour from the time to remove the pump; and the pump was subsequently removed and patient was given oral medication.It was also reported that the pump would occasionally alarm "reservoir volume not in use" and it was confirmed by the nurse case manager that the pump continued to run and infuse with no issue.Per reporter the patient's caregiver was advised that the "alarm could occur due to brushing the screen and hitting buttons in error." it was reported that "when this occurs the patient "crashes" he clarified as "severe off time." it was also reported that the pump alarmed "no disposable" and that the alarm was cleared by removing and reattaching cassettes or cleaning the sensors.Per reporter "currently the pump is working very well.".

• 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: 10271603
• MDR Text Key: 198739319
• Report Number: 3012307300-2020-07299
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: 21-1400-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2015
• 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