PEDIATRIC BIOMEDICUS FEMORAL CANNULA 96820-008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-30 for PEDIATRIC BIOMEDICUS FEMORAL CANNULA 96820-008 manufactured by Perfusion Systems.

MAUDE Entry Details

Report Number2184009-2020-00008
MDR Report Key9646303
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-30
Date of Report2020-03-30
Date of Event2020-01-11
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-01-21
Date Added to Maude2020-01-30
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1PERFUSION SYSTEMS
Manufacturer Street7611 NORTHLAND DR
Manufacturer CityBROOKLYN PARK MN 55428
Manufacturer CountryUS
Manufacturer Postal Code55428
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePEDIATRIC BIOMEDICUS FEMORAL CANNULA
Generic NameCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-01-30
Returned To Mfg2020-02-05
Model Number96820-008
Catalog Number96820-008
Lot Number2019010396
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPERFUSION SYSTEMS
Manufacturer Address7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

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