CLEARLINK BLOOD RECIPIENT SET FNC1173

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-11 for CLEARLINK BLOOD RECIPIENT SET FNC1173 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[170435793] (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[170435834] It was reported that a? Piece of the tubing? Attached to the top of the filter chamber of a clearlink blood recipient set disconnected resulting in a loss of a portion of the blood this occurred during use on a patient in the general patient ward. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2019-06841
MDR Report Key9453727
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-12-11
Date of Report2020-02-25
Date of Event2019-10-21
Date Mfgr Received2020-02-10
Date Added to Maude2019-12-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
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 - SINGAPORE
Manufacturer Street2 WOODLANDS INDUSTRIAL PARK D
Manufacturer CitySINGAPORE 738750
Manufacturer CountrySN
Manufacturer Postal Code738750
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK BLOOD RECIPIENT SET
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2019-12-11
Model NumberNA
Catalog NumberFNC1173
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-11

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