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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM 2400, BASE PLATE MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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BAXTER HEALTHCARE CORPORATION EM 2400, BASE PLATE MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 2400B
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the base plate of an exacta mix automated compounding device was contaminated; further described as microbial growth.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed which noted the device had a physical damage to the display arm bracket; arm was not intact.The reported condition was verified as physical damaged to the base plate.The cause of the physical damage to the base plate was due to ingredient spills (contamination) that may have not been properly and immediately cleaned.The base plates are not serviceable and will be scrapped.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EM 2400, BASE PLATE MODULE
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11608208
MDR Text Key243577690
Report Number1416980-2021-01827
Device Sequence Number1
Product Code NEP
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/02/2021
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 Number2400B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Initial Date Manufacturer Received 03/10/2021
Initial Date FDA Received04/02/2021
Supplement Dates Manufacturer Received04/23/2021
Supplement Dates FDA Received05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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