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,health report with the FDA on 2020-01-13 for CLEARLINK BLOOD RECIPIENT SET 2C8750 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[174884915] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[174884916] It was reported 6 clearlink system y-type blood/solution sets when used with a baxter pump alarmed? Air-in-line?. It was further reported there was "no air in line and lines being primed and programmed correctly". The nurse attempted to? Re-prime the blood set or switch the entire tubing out completely?. The event occurred during blood transfusions. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[179865936] Additional information: the actual device was not available; however, a four (4) companion samples were received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. The device was primed and functionally tested, and the clearlink performed according to product specifications. The reported condition was not verified. The remaining devices were not received for evaluation; therefore, a device analysis could not be completed. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1416980-2019-07540
MDR Report Key9583017
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-13
Date of Report2020-02-12
Date of Event2019-12-16
Date Mfgr Received2020-01-31
Device Manufacturer Date2019-06-11
Date Added to Maude2020-01-13
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 - 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 Received2020-01-13
Model NumberNA
Catalog Number2C8750
Lot NumberDR19F10062
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-13

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