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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 Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an exactamix 2400 compounder, main module was missing four (4) feet which secure the baseplate.The missing rubber feet on the baseplate where discovered while replacing the main module with a backup.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed, and it was noted that the device was missing the four rubber feet and four feet screws that fastens them to struts on bottom enclosure of the unit.The cause of the condition was not determined.To correct the condition, the four rubber feet and four screws were replaced and correctly fastened and torqued to specification.The device was serviced to meet function specification.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
 
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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
MDR Report Key9661720
MDR Text Key178039103
Report Number1416980-2020-00376
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
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 Manufacturer01/22/2020
Date Manufacturer Received02/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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