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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/CONTINU-FLO/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER INTERNATIONAL INC. CLEARLINK/CONTINU-FLO/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2C8541
Patient Problem Chemical Exposure (2570)
Event Date 11/09/2023
Event Type  malfunction  
Event Description
Patient noted leakage onto the floor below from y-site (right below the pump) on tubing while enhertu infused at 200 ml/hr.Arrived and line clamped.(47.5 mls infused) pharmacist and second rn arrived with spill kit.Estimated about 5-7 mls on floor, spill kit contents use per protocol.Port flushed, capped, and transferred patient to another treatment chair.Per discussion and order by dr, pharmacy calculated and remixed the rest of enhertu (150 mg) infused and completed as per order without incidence.Manufacturer response for iv tubing, continu-flo solution set, non-vented, 0.2 micron filter, 2 clearlink luer activated valve, backcheck valve.10 drops/ml.(per site reporter).
 
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Brand Name
CLEARLINK/CONTINU-FLO/DUO-VENT
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key18516889
MDR Text Key332882697
Report Number18516889
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 Nurse
Type of Report Initial
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2C8541
Device Catalogue Number2C8541
Device Lot NumberR23A20048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2023
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/16/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/16/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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