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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938724
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2022
Event Type  malfunction  
Event Description
It was reported that lipids were observed in an unspecified quantity of an em2400 valve sets unexpectedly.The issue was identified during the unspecified process step.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H10: the devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
VALVE SET, EM2400
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
AVAILMED
c. industrial lt 001 mz 105
no 20905 int a, col cd ind.
tijuana, baja california 22444
MX   22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key16151124
MDR Text Key308846239
Report Number1416980-2022-07375
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberH938724
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SMOFLIPIDS.
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