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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938741
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 08/29/2020
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 3000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was defective.The defect was further described as a leak coming from an unknown location.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d10, h3 and h6 (replace 4114 with 10, 3221 with 114).H10: the device was received for evaluation.Unaided visual inspection was performed which observed a small tear at the middle right side of the bag.Functional testing was performed which revealed a leak on the affected location.Additional magnified inspection was performed which verified a tear/hole where the leak was located.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
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
3000 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10567369
MDR Text Key207942404
Report Number1416980-2020-05887
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477251
UDI-Public(01)00085412477251
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,Followup
Report Date 11/06/2020
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 Expiration Date01/31/2023
Device Catalogue NumberH938741
Device Lot Number60228981
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received09/22/2020
Supplement Dates Manufacturer Received10/22/2020
11/03/2020
Supplement Dates FDA Received10/27/2020
11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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