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

Model Number 1400

Device Problems Fluid/Blood Leak (1250); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a healthcare professional that a battery used in a cadd® cadd-legacy® duodopa pump was found to be leaking.The pump was being used for infusion of levodopa/carbidopa.There was no reported patient adverse effect.

Manufacturer Narrative

One cadd® cadd-legacy® duodopa pump was returned for analysis in used condition.The pump had signs of impact and housing damage.The batteries were not returned with the pump.The customer problem confirmed in that the pump's battery compartment showed signs of contamination, which appears to be from the batteries rusting and not from them leaking internally.The pump showed signs of fluid ingression both internal to the pump and within the battery compartment.The root cause is user interface with the product in a manner inconsistent with the information for use (ifu).

• Brand Name: CADD® CADD-LEGACY® DUODOPA
• 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 north; minneapolis 55442 ; 7633833310
• MDR Report Key: 6882565
• MDR Text Key: 87232019
• Report Number: 3012307300-2017-02058
• 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: distributor,foreign,health pr
• 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: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• 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?: Yes
• Date Device Manufactured: 01/03/2013
• 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