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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 Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Event date: the event occurred on an unspecified date in 2019. (b)(6). (b)(4). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that three (3) 3000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were 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.

 
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Brand Name3000 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
see h10
tijuana, baja california 22444
MX 22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10589911
MDR Text Key208719067
Report Number1416980-2020-05997
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PHARMACIST
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/28/2020
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 OTHER
Device Catalogue NumberH938741
Device LOT Number60108448
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 Received10/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0167-2020

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