CLEARLINK BLOOD RECIPIENT SET 4C8723

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-30 for CLEARLINK BLOOD RECIPIENT SET 4C8723 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185519136] (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185519137] It was reported that two units of access blood solution sets leaked during patient use. The leaks were observed at the side of the pressure pump chamber of the sets while the patient was connected. It was reported the patient was on the way to the intensive care unit and? Eventually passed away?. The cause of death was unknown. It was not reported if an autopsy was performed. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-01818
MDR Report Key9897813
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-30
Date of Report2020-03-30
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-11-27
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - CARTAGO
Manufacturer StreetSEE H10 SEE H10
Manufacturer CityCARTAGO 30106
Manufacturer CountryCS
Manufacturer Postal Code30106
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK BLOOD RECIPIENT SET
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2020-03-30
Model NumberNA
Catalog Number4C8723
Lot NumberR19K23082
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-30

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