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

Model Number 1400

Device Problem Self-Activation or Keying (1557)

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

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a patient receiving levodopa/carbidopa via a smiths medical cadd-legacy® duodopa pump had mistakenly pushed the dose button for the morning button.The stop/activation button; leading to the pump displaying "stop." there were no adverse patient effects reported.

Manufacturer Narrative

Additional information was received that the patient did not receive an extra dose of medication after mistakenly pushing the dose button.There were no reported adverse effects.

• Brand Name: 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; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7278945
• MDR Text Key: 100472659
• Report Number: 3012307300-2018-00293
• 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,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-09
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1