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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER INTERNATIONAL INC. CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2H7462
Device Problem Failure to Infuse (2340)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2018
Event Type  malfunction  
Event Description
Patient has had an iv pump at his bedside for which the rn hung ivpg of zosyn, connecting the secondary tubing to the primary tubing.She set the pump in a manner to allow for the zosyn to infuse.However, the medication did not infuse.The clamp on the tubing was open.Rn changed the secondary iv tubing to a new set of the same kind and the same problem occurred; the medication did not infuse.A video clip of biomed testing verified that the primary bag would back feeds into the secondary line/bag, possible issue with backflow valve.
 
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Brand Name
CLEARLINK/DUO-VENT
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key7288635
MDR Text Key100677752
Report Number7288635
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2H7462
Device Catalogue Number2H7462
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/05/2018
Event Location Hospital
Date Report to Manufacturer02/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
IV PUMP AND PRIMARY TUBING
Patient Age42 YR
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