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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION
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BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number 2C8750
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
This report summarizes 1 malfunction events.It was reported that a clearlink y-type blood/solution set was unable to connect to a baxter clearlink set or baxter one-link set during set-up.The reporter stated that the luer lock would not screw in.This was identified prior to patient use.There was no patient involvement.No additional information is available.
 
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Brand Name
CLEARLINK BLOOD RECIPIENT SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
haina, san cristobal
Manufacturer (Section G)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina, san cristobal 91000
DR   91000
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8293790
MDR Text Key134742803
Report Number1416980-2019-00468
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)Y
Report Source Manufacturer
Type of Report Initial
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2C8750
Device Lot NumberASKU
Date Manufacturer Received12/31/2018
Type of Device Usage N
Patient Sequence Number1
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