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

Catalog Number 21-1400-06

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).Manufacturing date could not be determined with the information provided.

Event Description

It was reported that the morning dose is not correct while using a cadd® cadd-legacy® duodopa pump.No report of patient injury.

• Brand Name: CADD® CADD-LEGACY® DUODOPA 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: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7928003
• MDR Text Key: 122457257
• Report Number: 3012307300-2018-04120
• 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: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-1400-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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