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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number R21120046
Device Problems Crack (1135); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
Infusion tubing noted to be have a crack in the connection by the lipid port causing the fluids to backup and result in clotting of the line.
 
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Brand NameCLEARLINK
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key15224374
MDR Text Key297886130
Report Number15224374
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 Risk Manager
Type of Report Initial
Report Date 08/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberR21120046
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/01/2022
Event Location Hospital
Date Report to Manufacturer08/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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