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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX EVA TPN BAGS; TUBING SETS FOR PHARMACY COMPOUNDER; 2000ML; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION EXACTAMIX EVA TPN BAGS; TUBING SETS FOR PHARMACY COMPOUNDER; 2000ML; SET, I.V. FLUID TRANSFER Back to Search Results
Lot Number 60051309
Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2018
Event Type  malfunction  
Event Description
The event involved tpn bags that had been processed by the pharmacist, that would have been sent to various in patient units.I do not have specific dates/times, but four issues occurred in the past week.1 bag was reported that the blue rubber stopper went inside of the bag.Two days later, a bag was reported leaking, and 4 days after that another 2 bags were leaking.Baxter was notified of the incident by the pharmacy operations manager.The lot# 60051309 was pulled off of the shelves and replaced with another lot# and there have not been any identified issues with them.Leaking was noted to be coming from the middle port.
 
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Brand Name
EXACTAMIX EVA TPN BAGS; TUBING SETS FOR PHARMACY COMPOUNDER; 2000ML
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key7586583
MDR Text Key110647852
Report Number7586583
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/01/2020
Device Lot Number60051309
Other Device ID NumberCONTROL# H938740
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; THE EVENT INVOLVED TPN BAGS THAT HAD BEEN PROCESSE
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