CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET 2C8750 2C8750 S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET 2C8750 2C8750 S manufactured by Baxter Healthcare Corporation.

Event Text Entries

[184068975] The blood product tubing leaked at the bottom of the filter chamber. The outer plastic ring was not sealed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9853099
MDR Report Key9853099
Date Received2020-03-19
Date of Report2020-02-11
Date of Event2020-02-10
Report Date2020-03-03
Date Reported to FDA2020-03-03
Date Reported to Mfgr2020-03-19
Date Added to Maude2020-03-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2020-03-19
Model Number2C8750
Catalog Number2C8750 S
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer Address25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US 60073


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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