AFFINITY CP CENTRIFUGAL PUMP CBAP40

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 2020-03-30 for AFFINITY CP CENTRIFUGAL PUMP CBAP40 manufactured by Medtronic Mexico.

MAUDE Entry Details

Report Number2184009-2020-00021
MDR Report Key9896813
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-15
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-07-03
Date Added to Maude2020-03-30
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC MEXICO
Manufacturer StreetAV. PASEO DEL CUCAPAH #10510
Manufacturer CityTIJUANA,BC 22570
Manufacturer CountryMX
Manufacturer Postal Code22570
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAFFINITY CP CENTRIFUGAL PUMP
Generic NameTUBING, PUMP, CARDIOPULMONARY BYPASS
Product CodeDWE
Date Received2020-03-30
Model NumberCBAP40
Catalog NumberCBAP40
Lot Number218026105
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC MEXICO
Manufacturer AddressAV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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