FDA.reportPublic FDA data

MAUDE MDR 9690044

MDR report key
9690044
Report number
2916596-2020-00526
Event key
0
Event type
3
Date of event
2020-01-23
Date received
2020-02-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BOB FRYC
Address
6035 STONERIDGE DRIVE PLEASANTON CA 94588 US
Phone
781-781-7818
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EM-TEC ADULT FLOW PROBECONTROL, PUMP SPEED, CARDIOPULMONARY BYPASSTHORATEC SWITZERLAND GMBHDWA201-30105201-30105R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-100

Event Narratives#

N

Patient 1

NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

D

Patient 1

IT WAS REPORTED THAT THE CENTRIMAG CONSOLE ALARMED BATTERY MODULE FAIL TWICE AND THE ALARM HASN'T REPEATED. THE DOCTOR WAS AT THE BEDSIDE WHEN THIS HAPPENED AND ELECTED NOT TO CHANGE THE CONSOLE. IT WAS REPORTED IT WAS ADVISED TO KEEP A BACKUP AVAILABLE AND NOT TRANSPORT THE PATIENT WITHOUT BEING INFORMED. THE BATTERY INDICATOR SHOWS 3.45H AND THE CONSOLE HAS BEEN PLUGGED IN THE ENTIRE TIME. THE RPMS WERE 3800 WITH 4.5 L/MIN FLOW. NO ADVERSE EVENT REPORTED, AND NO ADDITIONAL INFORMATION REPORTED.