FDA.reportPublic FDA data

MAUDE MDR 9908120

MDR report key
9908120
Report number
2916596-2020-01831
Event key
0
Event type
3
Date of event
2019-12-01
Date received
2020-03-31
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
1HEARTMATE 3 SYSTEM CONTROLLERVENTRICULAR (ASSISST) BYPASSTHORATEC CORPORATIONDSQ106531US106531US6968737Y *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BACKUP BATTERY FAULT ALARM WAS CONFIRMED BASED ON THE INFORMATION RECORDED IN THE LOG FILE. THE DATA LOG FILE WAS SUCCESSFULLY RETRIEVED FROM THE RETURNED SYSTEM CONTROLLER SERIAL NUMBER (B)(4) AND CONTAINED EVENTS RECORDED FROM (B)(6) 2019 WHERE A BACKUP BATTERY FAULT ALARM ASSOCIATED WITH A BATTERY LOAD TEST FAILURE WAS RECORDED THROUGH THE ENTIRE LOG FILE. THE PUMP SUPPORT WAS NOT AFFECTED AND THE SYSTEM MAINTAINED THE DESIRED SET SPEED. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED USING THE LABORATORY EQUIPMENT AND WAS FOUND TO FUNCTION AS INTENDED. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE CONTROLLER PASSED ALL TEST STEPS. THE SYSTEM CONTROLLER OPERATED FOR EXTENDED PERIOD OF TIME WHILE CONNECTED TO A MOCK CIRCULATORY LOOP AND THE BACKUP BATTERY FAULT ALARM WAS NOT ABLE TO BE REPRODUCED. DURING TESTING, MULTIPLE LOAD TESTS WERE PERFORMED AND THE CONTROLLER PASSED EACH TIME WITHOUT ISSUE. A SPECIFIC ROOT CAUSE OF THE BACKUP BATTERY LOAD TEST FAILURE RECORDED IN THE LOG FILE WAS UNABLE TO BE CONCLUSIVELY DETERMINED DURING THIS INVESTIGATION. THE BACKUP BATTERY FAULT ALARM OBSERVED IN THE LOG FILE DID NOT AFFECT THE CONTROLLER'S ABILITY TO SUPPORT THE PUMP AT THE SET SPEED. ABBOTT IS CONTINUING TO MONITOR THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACKUP BATTERY FAULT ALARM. PATIENT'S BACKUP BATTERY WAS REPLACED, HOWEVER THE ALARM RETURNED SO THE PATIENT'S CONTROLLER WAS EXCHANGED WITH NO ISSUE. NO FURTHER INFORMATION PROVIDED.