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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER CLEAR LINK SYSTEM: Y-TYPE BLOOD/SOLUTION SET; SET, BLOOD TRANSFUSION

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BAXTER HEALTHCARE CORPORATION BAXTER CLEAR LINK SYSTEM: Y-TYPE BLOOD/SOLUTION SET; SET, BLOOD TRANSFUSION Back to Search Results
Model Number 4C8723
Device Problems Fluid/Blood Leak (1250); Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 03/03/2021
Event Type  malfunction  
Event Description
Anesthesia providers reported 5-6 defective pressure pumps from the same lot number.During the induction of anesthesia with propofol, the sets leaked and sprayed lactated ringers solution out of the pressure pump component, where the center plastic section of the pump meets the end piece of the pump.The y-type iv set had to be switched out for another set.Briefly disrupted critical care process, and sprayed ringers solution on provider and patient.No known harm to patient or staff.Fda safety report id# (b)(4).
 
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Brand Name
BAXTER CLEAR LINK SYSTEM: Y-TYPE BLOOD/SOLUTION SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL 60015
MDR Report Key11472738
MDR Text Key240058652
Report NumberMW5099964
Device Sequence Number1
Product Code BRZ
UDI-Device Identifier00085412049076
UDI-Public(01)00085412049076
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/05/2021
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 Health Professional
Device Model Number4C8723
Device Catalogue Number4C8723
Device Lot NumberR20J19071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/11/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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