MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE EM 2400, DISPLAY MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400D

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Visual inspection revealed that the power cable was pinched.Functional testing including power on and boot up testing was performed with no issues noted.The reported condition was verified.The cause of the condition was not determined.The power cord was replaced to resolve the issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that the display cord of an exactamix display module was frayed and the wires were exposed.There was no patient involvement.No additional information is available.

• Brand Name: EM 2400, DISPLAY MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8535700
• MDR Text Key: 142891986
• Report Number: 1416980-2019-02133
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/22/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 2400D
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1