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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK Y-TYPE BLOOD SOLUTION SET; SET, BLOOD TRANSFUSION
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BAXTER HEALTHCARE CORPORATION CLEARLINK Y-TYPE BLOOD SOLUTION SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number 2C8750S
Device Problems Fluid/Blood Leak (1250); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2016
Event Type  malfunction  
Event Description
Halfway through a two hour transfusion, the patient called out to the nurse that something was wrong.Blood was leaking out during therapy.When the nurse responded, she saw that the tubing had pulled apart.It was not known if the patient had done this.They did not state that they had pulled on the tubing.The separation of the tubing was at the final luer connector of this solution set.Unfortunately, the luer fitting was not saved, only the tubing.
 
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Brand Name
CLEARLINK Y-TYPE BLOOD SOLUTION SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
rlt-10
round lake IL 60073
MDR Report Key5852926
MDR Text Key51369297
Report Number5852926
Device Sequence Number1
Product Code BRZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/02/2016
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 Lay User/Patient
Device Catalogue Number2C8750S
Device Lot Number07-36-69-408
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer08/02/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO. THE PATIENT WAS IN THE MIDDLE OF HIS TRANSFUSI
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