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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2C8541
Device Problem Reflux within Device (1522)
Patient Problem Underdose (2542)
Event Date 06/25/2018
Event Type  malfunction  
Event Description
A primary bag of dextrose 5% sodium chloride.15% set up with secondary bag of methotrexate and upon checking the bag to see if the secondary infusion was complete the bag of methotrexate (yellow in color) had been back flowing into the primary bag of fluid in addition to running into the patient line.As a result the patient needed to receive an extra 400ml of fluid to complete the entire dose of methotrexate and the infusion took 4 hours longer than anticipated due to patient size and corresponding fluid rate.Per site reporter: i am waiting for shipping material from manufacturer.
 
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Brand Name
CLEARLINK/CONTINU-FLO/DUO-VENT
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key7654593
MDR Text Key112887636
Report Number7654593
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2C8541
Device Catalogue Number2C8541
Device Lot NumberR18D04095
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2018
Event Location Other
Date Report to Manufacturer07/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age1460 DA
Patient Weight15
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