FDA.reportPublic FDA data

MAUDE MDR 310993

MDR report key
310993
Report number
2916596-2000-00032
Event key
0
Event type
3
Date of event
2000-11-26
Date received
2000-12-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GARY CEDERWALL
Address
6035 STONERIDGE DRIVE PLEASANTON CA 94588 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEMVENTRICULAR ASSIST DEVICE, DRIVERTHORATEC LABORATORIES CORP.DSQNA10025-2600-005NAP8700YNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-12-2801. R

Event Narratives#

D

Patient 1

A PT WAS BEING SUPPORTED BY LEFT AND RIGHT VENTRICULAR ASSIST DEVICES (LVAD AND RVAD), WHEN THE DISPLAY PANEL ON THE TOP MODULE OF THE DUAL DRIVE CONSOLE (DDC) FROZE AND THE VAD STOPPED PUMPING. THE PT WAS HAND PUMPED USING THE EMERGENCY HAND PUMP UNTIL THE DDC WAS REPLACED. THE PT EXPERIENCED BRIEF HYPOTENSION, BUT RECOVERED WITH NO ADVERSE EFFECTS. THE FAILURE WAS RECREATED AT THE SITE BY THE USER AND THE MALFUNCTION WAS TRACED TO A PRINTED CIRCUIT BOARD. THE CAUSE OF THE BOARD MALFUNCTION HAS NOT BEEN DETERMINED. THE CIRCUIT BOARD WILL BE RETURNED TO THORATEC'S MANUFACTURING FACILITY FOR FURTHER EVALUATION. ANY NECESSARY CORRECTIVE ACTION WILL BE DETERMINED UPON COMPLETION OF THE FAILURE INVESTIGATION.