FDA.reportPublic FDA data

MAUDE MDR 332304

MDR report key
332304
Report number
2916596-2001-00014
Event key
0
Event type
3
Date of event
2001-04-07
Date received
2001-05-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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 CORP.DSQNA10025-2600-005NAP8700YYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-05-0701. R

Event Narratives#

D

Patient 1

WHEN A PATIENT WAS CONNECTED TO THE UPPER MODULE OF THE DUAL DRIVE CONSOLE (DDC), THE DRIVER DID NOT FUNCTION. THE PATIENT WAS SWITCHED TO A BACK UP DRIVER WITHOUT INCIDENT. VISUAL INSPECTION OF THE UNIT WAS CONDUCTED BY A BIOMEDICAL TECHNICIAN AT THE SITE, AND THE FAILURE WAS TRACED TO A KINK IN THE PNEUMATIC TUBING THAT CONNECTS THE SOLENOID PILOT VALVE TO THE PRESSURE INPUT OF THE 3-WAY VALVE THAT CONTROLS THE VAD DRIVELINE PRESSURE. A KINK IN THE TUBING CAN CAUSE FAILURE OF THE MODULE TO PROVIDE ADEQUATE PNEUMATIC DRIVE PRESSURE TO THE VAD. THE KINK IN THE TUBING WAS RELIEVED, WHICH CORRECTED THE PROBLEM. THE CAUSE OF THE KINKING IS UNKNOWN. NO CORRECTIVE ACTION HAS BEEN IMPLEMENTED, AS THE CAUSE OF THE KINK IN THE PNEUMATIC TUBING IS UNKNOWN. SINCE THIS IS ONLY THE FIRST INCIDENT OF THIS KIND, THORATEC PLANS TO MONITOR AND TRACK FOR SIMILAR INCIDENTS.