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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK SYSTEM, Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER; SET, BLOOD TRANSFUSION

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BAXTER INTERNATIONAL INC. CLEARLINK SYSTEM, Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER; SET, BLOOD TRANSFUSION Back to Search Results
Model Number 2C8750
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 10/19/2018
Event Type  malfunction  
Event Description
Patient receiving blood transfusion.About 1.5 hours into blood transfusion, treating rn noticed the blood tubing/blood tubing filter chamber was completely full (it hadn't been) and blood appeared to be leaking down the side of the filter chamber.Transfusion was stopped, charge nurse in to assess situation.Could not tell where blood was leaking from, but it was determined that the iv tubing was no longer a closed system (had been compromised) and transfusion was terminated.Appeared to be a blood tubing malfunction.Lot # on blood tubing is lot (10)dr18b10021.Tubing is baxter clearlink system, y-type blood/solution set with standard blood filter.
 
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Brand Name
CLEARLINK SYSTEM, Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key8008649
MDR Text Key125149713
Report Number8008649
Device Sequence Number1
Product Code BRZ
UDI-Device Identifier00085412046341
UDI-Public(01)00085412046341
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 10/21/2018
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 Operator No Information
Device Model Number2C8750
Device Catalogue Number2C8750
Device Lot Number(10)DR18B10021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/26/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age31390 DA
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