DLP LEFT HEART VENT CATHETER 12016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-06-12 for DLP LEFT HEART VENT CATHETER 12016 manufactured by Perfusion Systems.

MAUDE Entry Details

Report Number2184009-2019-00038
MDR Report Key8691949
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2019-06-12
Date of Report2019-07-22
Date of Event2019-01-25
Date Mfgr Received2019-07-03
Date Added to Maude2019-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHYSICIAN ASSISTANT
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 NameDLP LEFT HEART VENT CATHETER
Generic NameSUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
Product CodeDTS
Date Received2019-06-12
Model Number12016
Catalog Number12016
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Required No Informationntervention 2019-06-12

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