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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION EM 2400, MAIN MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 2400M
Device Problems Crack (1135); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Manufacturer Narrative
The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the green door of an exactamix automated compounding device was cracked. It was further reported that the power cord had exposed wires. There was no patient involvement. No additional information is available.
 
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Brand NameEM 2400, MAIN MODULE
Type of DeviceSYSTEM/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 Key12623733
MDR Text Key276165129
Report Number1416980-2021-06234
Device Sequence Number1
Product Code NEP
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2400M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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