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

Model Number 1400

Device Problems Corroded (1131); Difficult to Open or Remove Packaging Material (2922)

Patient Problem Not Applicable (3189)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

One smiths medical cadd-legacy® duodopa pump was returned for analysis.The complaint was confirmed in that the battery door was hard to open.This was found to be a result of contamination of a leaking battery.Based on the evidence, it is unknown as to what caused the leakage and the issue will be monitored.

Event Description

Information was received indicating that the battery door to a smiths medical cadd-legacy® duodopa pump was reported to be impossible to open.There were no adverse effects reported.

• Brand Name: CADD-LEGACY® PCA 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 n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7325513
• MDR Text Key: 101979693
• Report Number: 3012307300-2018-00515
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1