CLEARLINK BLOOD RECIPIENT SET 2C8750

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 2020-02-26 for CLEARLINK BLOOD RECIPIENT SET 2C8750 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[180868383] (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[180868384] It was reported that two clearlink system y-type blood/solution sets were leaking. After 5 minutes of platelet infusion, the set was observed to be leaking at the distal end of the tubing just above the luer lock. The customer attempted to resolve the issue by replacing the set and spiking a second bag of platelets; however, the leak was observed again at the distal end of the tubing just above the luer lock. The platelet transfusion was completed without difficulty after the set was changed again. 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 Number1416980-2020-00966
MDR Report Key9753279
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-02-26
Date of Report2020-03-26
Date of Event2020-01-24
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-10-16
Date Added to Maude2020-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 - DOMINICAN REPUBLIC
Manufacturer StreetCARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA
Manufacturer CityHAINA, SAN CRISTOBAL
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK BLOOD RECIPIENT SET
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2020-02-26
Returned To Mfg2020-03-05
Model NumberNA
Catalog Number2C8750
Lot NumberDR19J15023
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.