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

Catalog Number 2400M

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 supporting leg was broken.The reported condition was verified.The kickstand assembly was replaced to resolve the issue.A device history review revealed no issues that could have caused or contributed to the reported 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 supporting leg of an exactamix compounding device was broken.This occurred during priming.There was no patient involvement.No additional information is available.

• Brand Name: EM 2400, MAIN 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: 8831460
• MDR Text Key: 152534555
• Report Number: 1416980-2019-04045
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2400M
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1