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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION EM 2400, MAIN COMPOUNDER 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 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the green pump door of an exactamix automated compounding device has missing parts.It was further reported the green door had missing screws.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection was performed which noted the device was missing the screws from the green door.Functional and electrical testing was performed with no issues noted.The reported condition was verified.The cause of the missing screws was likely from normal everyday use.To correct the condition, the door and screws will be replaced during refurbishment of main module.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EM 2400, MAIN COMPOUNDER MODULE
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11089748
MDR Text Key224761657
Report Number1416980-2020-08161
Device Sequence Number1
Product Code NEP
UDI-Device Identifier00085412482637
UDI-Public(01)00085412482637
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,consum
Type of Report Initial,Followup
Report Date 01/28/2021
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 Number2400M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2020
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received01/19/2021
Supplement Dates FDA Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.
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