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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 4000 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION 4000 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938742
Device Problem Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 09/02/2020
Event Type  Malfunction  
Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from an unspecified location. The leak was discovered at the inpatient pharmacy after being compounded. There was no patient involvement. No additional information is available.

 
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Brand Name4000 ML TPN BAG
Type of DeviceSET, 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 Key10590294
MDR Text Key208720178
Report Number1416980-2020-06015
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
Reporter Country CodeCA
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberH938742
Device LOT Number60147016
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Is this a Reprocessed and Reused Single-Use Device? No

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