FDA.reportPublic FDA data

MAUDE MDR 9908355

MDR report key
9908355
Report number
2916596-2020-01690
Event key
0
Event type
3
Date of event
2020-01-07
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 CORPORATIONDSQ106531US106531US6545154Y R

Patients#

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

Event Narratives#

N

Patient 1

MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF BACKUP BATTERY FAULT ALARMS WAS CONFIRMED VIA THE SUBMITTED AND DOWNLOADED LOG FILES. THE SYSTEM CONTROLLER (SERIAL #: (B)(4)) WAS RETURNED FOR ANALYSIS AND A LOG FILE WAS SUBMITTED FOR REVIEW (B)(4) AS WELL AS DOWNLOADED FROM THE RETURNED CONTROLLER FOR REVIEW (B)(4). A REVIEW OF THE LOG FILES SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 3 DAYS ((B)(6) 2020 PER TIME STAMP). BACKUP BATTERY FAULT ALARMS WERE ACTIVE DUE TO A LOAD TEST FAILURE. THE BACKUP BATTERY FAULT ALARMS WERE ACTIVE BETWEEN (B)(6) 2020 AT 17:52:20 TO (B)(6) 2020 AT 13:15:01. THE BACKUP BATTERY FAILED THE LOAD TEST DUE TO THE LOADED VOLTAGE BEING UNDER THE ACCEPTABLE THRESHOLD AS COMPARE TO THE UNLOADED VOLTAGE. WHEN THE LOAD TEST FIRST FAILED, THE LOADED VOLTAGE MEASURED ~11.4V AND THE UNLOADED VOLTAGE MEASURED ~12.3V. PUMP OPERATION WAS NOT AFFECTED. THE SYSTEM CONTROLLER UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING. THE SYSTEM CONTROLLER WAS CONNECTED TO THE MOCK LOOP AND WAS ABLE TO OPERATE FOR AN EXTENDED OPERATION AS INTENDED. THE REPORTED BACKUP BATTERY FAULT ALARMS WERE NOT ABLE TO BE REPRODUCED DURING THIS INVESTIGATION. THE ROOT CAUSE FOR THE REPORTED EVENT WAS NOT ABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE INTERNAL BATTERY FAULTS. THE BATTERY WAS REPLACED SEVERAL TIMES AND THE BATTERY FAULTS STILL RETURNED. IT WAS SUGGESTED TO REPLACE THE CONTROLLER. THE CONTROLLER WAS EXCHANGED AND RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.