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

Model Number 1400

Device Problems Electrical /Electronic Property Problem (1198); Noise, Audible (3273)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/19/2017

Event Type  malfunction  

Event Description

Information was received indicating that this the patient with this ambulatory infusion pump reported that they felt electricity from the frequency of the pump.They also reported hearing human voices from the pump.No adverse patient effects were reported.

Manufacturer Narrative

Report source foreign: (b)(6).

• Brand Name: CADD® CADD-LEGACY® 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 road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7159873
• MDR Text Key: 96354444
• Report Number: 3012307300-2018-00018
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• 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: 12/21/2017
• 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: N
• Patient Sequence Number: 1