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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, BLOOD TRANSFUSION
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BAXTER INTERNATIONAL INC. CLEARLINK; SET, BLOOD TRANSFUSION Back to Search Results
Model Number 4H8723
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Event Description
Nursing staff were getting an icu room ready for a patient that was coming out of the or post-cardiac surgery.While staff began to ready the room, they hung 2 bags of iv fluids, using the 'baxter clearlink system y-type blood/solution set with large standard blood filter and pressure pump'.Once the rn prepped the lines with the iv solution, liquid began to shoot out of the line.Nursing staff stopped the flow and examined the line.There is a pen sized hole in the line at the connection of the blood filter and iv line that caused the fluid to shoot out.This instance did not cause any harm to a patient, but a large majority of the time these fluid lines are used for administering blood to patients, and if was an emergent situation, and this line was used, it could have caused harm to the patient by delaying care.
 
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Brand Name
CLEARLINK
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key12173239
MDR Text Key261702339
Report Number12173239
Device Sequence Number1
Product Code BRZ
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 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number4H8723
Device Catalogue Number4H8723
Device Lot NumberR21B15058
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/09/2021
Event Location Hospital
Date Report to Manufacturer07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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