BIO CONSOLE 560 560BCS1

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 2020-02-13 for BIO CONSOLE 560 560BCS1 manufactured by Perfusion Systems.

Event Text Entries

[179254859] The bio-console instrument was analysed by a medtronic field service technician and the reported ramp up to 6,000 rpm was verified during service. The issue was resolved by replacing the assy, 560 m/p module. Preventive maintenance was performed per specifications. Trends for this product are monitored. Device evaluation was carried out in the facility by a medtronic service technician. The date service was carried out has been used as the return date. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[179254860] Medtronic received information that during use this bio-console instrument ramped up to 6,000 rpm. The external motor drive was replaced and the issue occurred again. The instrument was changed out with a backup and there was no resulting adverse patient effect. It was reported that the customer used the hand crank when switching over between motors and bio-consoles.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2184009-2020-00009
MDR Report Key9705870
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-13
Date of Report2020-02-13
Date of Event2020-01-02
Date Mfgr Received2020-01-15
Device Manufacturer Date2018-01-23
Date Added to Maude2020-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter 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 NameBIO CONSOLE 560
Generic NameCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Product CodeDWA
Date Received2020-02-13
Returned To Mfg2020-01-15
Model Number560BCS1
Catalog Number560BCS1
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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 2020-02-13

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