MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION¿ MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP; ACCESSORIES, PUMP, INFUSION

Model Number 4000

Device Problems Smoking (1585); Flare or Flash (2942)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the power supply of a syringe infusion pump was "burnt up a bit/smoke".No patient involvement was reported.

• Brand Name: MEDFUSION¿ MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP
• Type of Device: ACCESSORIES, PUMP, INFUSION
• 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: 7801475
• MDR Text Key: 117749017
• Report Number: 3012307300-2018-03351
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4000
• Device Catalogue Number: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2012
• 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