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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938740
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from an unspecified location.The leak was identified during setup/preparation prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H4: the lot was manufactured from january 28, 2020 - january 29, 2020.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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
2000 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10634763
MDR Text Key209991901
Report Number1416980-2020-06204
Device Sequence Number1
Product Code LHI
Combination Product (y/n)Y
PMA/PMN Number
K900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberH938740
Device Lot Number60225035
Was Device Available for Evaluation? No
Date Manufacturer Received10/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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