MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD EM 2400, MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400M

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the em 2400 appeared to have a burnt power cord and "smoke was observed coming from the main module".The event occurred when cleaning the hood of the device.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation. visual inspection using unaided eye, under normal lighting and 18 inches from object,main module cover scratched paint and pump cover.The power cord was not returned with the unit, therefore the reported issue of burnt power cord can not be confirmed or refuted.The reported problem was not verified. the service history review conducted found no issues that could be related to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, MAIN MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9088565
• MDR Text Key: 159197497
• Report Number: 1416980-2019-05134
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1