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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION BAXTER EM2400 VALVE SET SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Lot Number 60334338
Device Problems Leak/Splash (1354); 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. This is a patient safety risk. 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 CORPORATION
MDR Report Key13949494
MDR Text Key288311391
Report NumberMW5108595
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 Number60334338
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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