ROTAFLOW CENTRIFUGAL PUMP SYSTEM ROTAFLOW ENGLISH/UK UK-PLUG ICU 70105.1697

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-11-30 for ROTAFLOW CENTRIFUGAL PUMP SYSTEM ROTAFLOW ENGLISH/UK UK-PLUG ICU 70105.1697 manufactured by Maquet Cardiopulmonary Gmbh.

MAUDE Entry Details

Report Number8010762-2019-00374
MDR Report Key9392251
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-11-30
Date of Report2019-11-28
Date of Event2019-05-23
Date Mfgr Received2019-11-15
Device Manufacturer Date2018-11-09
Date Added to Maude2019-11-30
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 StreetMAQUET CARDIOPULMONARY AG KEHLER STRASSE 31
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal76437
Manufacturer Phone4972229321
Manufacturer G1NURSEL BOELENS
Manufacturer StreetMAQUET CARDIOPULMONARY AG KEHLER STRASSE 31
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal Code76437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROTAFLOW CENTRIFUGAL PUMP SYSTEM
Generic NameCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Product CodeDTQ
Date Received2019-11-30
Model NumberROTAFLOW ENGLISH/UK UK-PLUG ICU
Catalog Number70105.1697
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOPULMONARY GMBH
Manufacturer AddressNEUE ROTTENBURGER STRASSE 37 HECHINGEN US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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