FDA.reportPublic FDA data

MAUDE MDR 305260

MDR report key
305260
Report number
2916596-2000-00029
Event key
0
Event type
3
Date of event
2000-10-11
Date received
2000-11-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GARY CEDERWALL
Address
6035 STONERIDGE DR 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 (VAD) BLOOD PUMPTHORATEC LABORATORIES CORP.DSQNA14086-2550-000NAYNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-11-0901. O

Event Narratives#

D

Patient 1

THE USER INDICATED THAT A PT UNDERWENT REOPERATION TO CHANGE THE VENTRICULAR ASSIST DEVICE (VAD) DUE TO HEMOLYSIS SUSPECTED TO BE RELATED TO THE DEVICE. THE EXPLANTED VAD WAS RETURNED UNSTERILE TO THORATEC'S MFG FACILITY FOR EVAL. FURTHER INVESTIGATION OF THE DEVICE WILL BE CONDUCTED AFTER THE VAD HAS BEEN STERILIZED. ANY NECESSARY CORRECTIVE ACTION WILL BE DETERMINED UPON COMPLETION OF THE FAILURE INVESTIGATION.