MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 COVER KIT; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 64000984

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that the green door of an automated compounding device was cracked.This occurred during an unspecified process step.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM2400 COVER KIT
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13044249
• MDR Text Key: 282961224
• Report Number: 1416980-2021-07429
• 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
• Report Date: 12/20/2021

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: 64000984
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1