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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed which revealed a damaged power cable.A service history review was performed with no service records found for this device.The reported condition was verified.The cause of the condition was determined to be a damaged power cable from an unknown origin.The power cable requires replacement to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the plug and cable for an exactamix compounder module was damaged.This was identified at an unspecified process step.There was no patient involvement.No additional information is available.
 
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Brand Name
EM 2400, MAIN MODULE
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
ECM - ENGLEWOOD
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key14686359
MDR Text Key294045021
Report Number1416980-2022-03091
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2400M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2022
Date Manufacturer Received05/18/2022
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 Reuse
Patient Sequence Number1
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