FDA.reportPublic FDA data

MAUDE MDR 355194

MDR report key
355194
Report number
2916596-2001-00026
Event key
0
Event type
3
Date of event
2001-09-06
Date received
2001-10-05
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 CEDERWAL
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, DRIVERTHORATEC CORPDSQNA10025-2600-005NAP8700YRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-10-050

Event Narratives#

D

Patient 1

A PT SUPPORTED WITH LEFT AND RIGHT VENTRICULAR ASSIST DEVICES (BIVAD) WAS BEING TRANSPORTED WHEN THE NURSE NOTICED THAT THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS NOT FILLING. THE LVAD WAS CONNECTED TO THE TOP DRIVE MODULE AT THAT TIME. THERE WAS NO EFFECT ON THE PT. THE PT WAS SWITCHED TO A BACK UP DRIVE CONSOLE. INITIAL EXAMINATION WAS PERFORMED ON THE UNIT BY THE SITE BIOMEDICAL ENGINEER AND THE PROBLEM WAS TRACED TO AN INTEGRATED CIRCUIT (IC) EPROM U14. THE IC CHIP WAS FOUND TO BE LOOSE ON THE CPU BOARD. THE CHIP WAS RESEATED AND THE PROBLEM WAS CORRECTED. PERFORMANCE TESTS SHOWED THAT THE DDC FUNCTIONED NORMALLY THEREAFTER. THE CAUSE OF THE LOOSE MOUNTING OF THE IC CHIP IS UNKNOWN. SINCE THIS IS AN ISOLATED INCIDENT, NO CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THORATEC PLANS TO MONITOR AND TRACK FOR SIMILAR INCIDENTS.