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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 Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2022
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation.Visual inspection revealed unknown fluids on the unit and damage to the rotor.Additionally damage to the housing was observed indicating the device may have been dropped or mishandled by the customer.Functional testing was performed which included hi-pot electrical safety test, functional system level system test, and functional system level ctf test with no issues noted.The device passed the functional tests.Device lifestats indicate unit was likely not even used by customer.The device operated as intended.The customer reported issue of lipids leaking was not reproduced or verified, using in house ingredients of 70% dextrose and sterile water.The device met specifications for the reported issue.The reported condition was not verified.A service history review revealed that the device had not been serviced in the last 12 months for the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an em 2400, main module automated compounding device (acd) that was used with an em2400 valve set leaked with lipids from port 1.This was found during programming/set up.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 Key14950596
MDR Text Key296056827
Report Number1416980-2022-03520
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
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 Other
Type of Report Initial
Report Date 07/07/2022
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 Number2400M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2022
Initial Date Manufacturer Received 06/10/2022
Initial Date FDA Received07/07/2022
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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