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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM1200 VALVE SET; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION EM1200 VALVE SET; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938792
Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that an exactamix em1200 valve set leaked.The port that connects to the empty bag, fully disconnected from the tubing resulting in leak of solution.This was observed during compounding.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was 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
EM1200 VALVE SET
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 Key18740246
MDR Text Key336198875
Report Number1416980-2024-00664
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 Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/20/2024
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 NumberH938792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2024
Initial Date FDA Received02/20/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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