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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 Deliver (2338)
Patient Problem Missed Dose (2561)
Event Date 11/26/2017
Event Type  malfunction  
Event Description
Noted full iv bag of vancomycin hanging from iv pole upon entering patient's room. Dose was scheduled to be hung prior day at 2100 and was charted as administered. Dose was not infused.
 
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Brand NameCLEARLINK/DUO-VENT
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key7221168
MDR Text Key98313054
Report Number7221168
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 Patient
Type of Report Initial
Report Date 12/21/2017,01/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2H7462
Device Catalogue Number2H7462
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2017
Event Location Hospital
Date Report to Manufacturer12/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/26/2018 Patient Sequence Number: 1
Treatment
IV PUMP: ALARIS PC CAREFUSION MODEL#8015- THE "BRA
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