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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. BAXTER EM2400 VALVE SET SYSTEM/DEVICE, PHARMACY COMPOUNDING

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BAXTER HEALTHCARE CORP. BAXTER EM2400 VALVE SET SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Lot Number 60331318
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 03/24/2022
Event Type  malfunction  
Event Description
Faulty valve sets to be used with automated compounding devices for compounding parenteral nutrition are permitting unintended mixing of ingredients to the final solution. Specifically, lipids have leaked into final product which was not to contain lipid. Fda safety report id# (b)(4).
 
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Brand NameBAXTER EM2400 VALVE SET
Type of DeviceSYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
MDR Report Key13949341
MDR Text Key288314571
Report NumberMW5108590
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number60331318
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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