THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

Report

Report Number: 2916596-2025-03221
Event Type: Malfunction
Date Received: May 29, 2025
Date of Event: February 19, 2025
Report Date: July 23, 2025
Manufacturer: THORATEC CORPORATION
Product Code: DSQ
UDI-DI: 00813024013235
PMA / PMN Number: P160054
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF CONTROLLER CLOCK CORRUPT ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILES. THE SYSTEM CONTROLLER WAS EVALUATED FOLLOWING THE REPORTED EVENT OF LOW PUMP CURRENT FAULTS. A REVIEW OF THE SUBMITTED CONTROLLER EVENT LOG FILE (113546) SPANNED APPROXIMATELY 3.5 HOURS ((B)(6) 2000 FROM 04:04:43 ¿ 05:55:37 AND (B)(6) 2025 FROM 09:31:00 ¿ 10:01:59 PER TIME STAMP). FROM THE BEGINNING OF THE LOG FILE, THERE WAS A CONTROLLER CLOCK CORRUPT ALARM ACTIVE. THIS IS INDICATIVE OF A LOSS OF POWER, BUT THE ONSET WAS OVERRIDDEN BY NEW EVENTS. THIS WILL RESET THE CLOCK TO A DEFAULT OF (B)(6) 2000. THE (B)(6) 2000 TIME STAMP IN THE LOG FILE WOULD MEAN THAT THIS EVENT OCCURRED ABOUT 49 DAYS PRIOR. THE ALARM REMAINED ACTIVE UNTIL THE CLOCK WAS SET ON (B)(6) 2025. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THERE WERE NO OTHER ALARMS ACTIVE IN THE LOG FILE. A REVIEW OF THE SUBMITTED CONTROLLER PERIODIC LOG FILE (113546) SPANNED APPROXIMATELY 13 DAYS AT 1-HOUR INTERVALS ((B)(6) 2000 ¿ (B)(6) 2000 AND(B)(6) 2025 PER TIME STAMP). FROM THE BEGINNING OF THE LOG FILE, THERE WAS A CONTROLLER CLOCK CORRUPT ALARM ACTIVE. THIS IS INDICATIVE OF A LOSS OF POWER, BUT THE ONSET WAS OVERRIDDEN BY NEW EVENTS. THERE WERE NO OTHER ALARMS ACTIVE IN THE LOG FILE. A REVIEW OF THE CONTROLLER EVENT LOG FILES (025919, 092955, AND E5190858) SPANNED APPROXIMATELY 2 DAYS ((B)(6) 2025¿(B)(6) 2025 PER TIME STAMP). FROM THE BEGINNING OF THE LOG FILE, THE LOW PUMP CURRENT FAULT (F17) WAS ACTIVE WITHOUT AN ASSOCIATED ALARM. THE FAULT WAS ACTIVE DUE TO A LOWER-THAN-EXPECTED ISENSE B PUMP CURRENT. THIS WILL BE COVERED UNDER THE PUMP INVESTIGATION IN PI-(B)(6). THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE RETURNED SYSTEM CONTROLLER, SERIAL (B)(6), WAS FUNCTIONALLY TESTED WITH THE RETURNED MODULAR CABLES AND WAS ABLE TO SUPPORT PUMP FUNCTION FOR AN EXTENDED PERIOD OF TIME. NO ATYPICAL ALARMS WERE REPRODUCED DURING TESTING. FUNCTIONAL TESTING REVEALED NO ISSUES WITH ISENSE VALUES IN THE SYSTEM CONTROLLER. PER THE ADDITIONAL INFORMATION, THE ROOT CAUSE FOR THE REPORTED CLOCK CORRUPT ALARM WAS DETERMINED TO BE USER ERROR BY LETTING THE BATTERIES FULLY DEPLETE. THE REPORTED EVENT OF LOW PUMP CURRENT FAULTS COULD NOT BE CORRELATED TO AN ISSUE WITH THE RETURNED SYSTEM CONTROLLER. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. D) SECTION 7- ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5- ¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO TROUBLESHOOT THE SYSTEM CONTROLLER, INCLUDING CONTROLLER CLOCK CORRUPT ALARMS. THE "POWERING THE SYSTEM" SECTION OF THE IFU INSTRUCTS THE PATIENT IN HOW TO SWITCH BETWEEN POWER SOURCES TO PREVENT LOSS OF POWER. THE "PATIENT CARE MANAGEMENT" SECTION OF THE IFU INSTRUCTS THE PATIENT TO KEEP A FLASHLIGHT, FULLY CHARGED BATTERIES, AND BATTERY CLIPS WITHIN REACH TO BE PREPARED FOR A POWER OUTAGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

Additional Manufacturer Narrative · 0

MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF CONTROLLER CLOCK CORRUPT ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILES. THE SYSTEM CONTROLLER WAS EVALUATED FOLLOWING THE REPORTED EVENT OF LOW PUMP CURRENT FAULTS. A REVIEW OF THE SUBMITTED CONTROLLER EVENT LOG FILE (B)(4) SPANNED APPROXIMATELY 3.5 HOURS (18FEB2000 FROM 04:04:43 ¿ 05:55:37 AND 08APR2025 FROM 09:31:00 ¿ 10:01:59 PER TIME STAMP). FROM THE BEGINNING OF THE LOG FILE, THERE WAS A CONTROLLER CLOCK CORRUPT ALARM ACTIVE. THIS IS INDICATIVE OF A LOSS OF POWER, BUT THE ONSET WAS OVERRIDDEN BY NEW EVENTS. THIS WILL RESET THE CLOCK TO A DEFAULT OF 01JAN2000. THE 18FEB2000 TIME STAMP IN THE LOG FILE WOULD MEAN THAT THIS EVENT OCCURRED ABOUT 49 DAYS PRIOR. THE ALARM REMAINED ACTIVE UNTIL THE CLOCK WAS SET ON (B)(6) 2025. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THERE WERE NO OTHER ALARMS ACTIVE IN THE LOG FILE. A REVIEW OF THE SUBMITTED CONTROLLER PERIODIC LOG FILE (B)(4) SPANNED APPROXIMATELY 13 DAYS AT 1-HOUR INTERVALS (07FEB2000 ¿ 18FEB2000 AND 08APR2025 PER TIME STAMP). FROM THE BEGINNING OF THE LOG FILE, THERE WAS A CONTROLLER CLOCK CORRUPT ALARM ACTIVE. THIS IS INDICATIVE OF A LOSS OF POWER, BUT THE ONSET WAS OVERRIDDEN BY NEW EVENTS. THERE WERE NO OTHER ALARMS ACTIVE IN THE LOG FILE. A REVIEW OF THE CONTROLLER EVENT LOG FILES (B)(4) SPANNED APPROXIMATELY 2 DAYS (06MAY2025¿ 07MAY2025 PER TIME STAMP). FROM THE BEGINNING OF THE LOG FILE, THE LOW PUMP CURRENT FAULT (F17) WAS ACTIVE WITHOUT AN ASSOCIATED ALARM. THE FAULT WAS ACTIVE DUE TO A LOWER-THAN-EXPECTED ISENSE B PUMP CURRENT. THIS WILL BE COVERED UNDER THE PUMP INVESTIGATION IN PI (B)(4). THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE RETURNED SYSTEM CONTROLLER, SERIAL (B)(6), WAS FUNCTIONALLY TESTED WITH THE RETURNED MODULAR CABLES AND WAS ABLE TO SUPPORT PUMP FUNCTION FOR AN EXTENDED PERIOD OF TIME. NO ATYPICAL ALARMS WERE REPRODUCED DURING TESTING. FUNCTIONAL TESTING REVEALED NO ISSUES WITH ISENSE VALUES IN THE SYSTEM CONTROLLER. A ROOT CAUSE FOR THE REPORTED CLOCK CORRUPT ALARM WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE REPORTED EVENT OF LOW PUMP CURRENT FAULTS COULD NOT BE CORRELATED TO AN ISSUE WITH THE RETURNED SYSTEM CONTROLLER. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. D) SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO TROUBLESHOOT THE SYSTEM CONTROLLER, INCLUDING CONTROLLER CLOCK CORRUPT ALARMS. THE "POWERING THE SYSTEM" SECTION OF THE IFU INSTRUCTS THE PATIENT IN HOW TO SWITCH BETWEEN POWER SOURCES TO PREVENT LOSS OF POWER. THE "PATIENT CARE MANAGEMENT" SECTION OF THE IFU INSTRUCTS THE PATIENT TO KEEP A FLASHLIGHT, FULLY CHARGED BATTERIES, AND BATTERY CLIPS WITHIN REACH TO BE PREPARED FOR A POWER OUTAGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

Additional Manufacturer Narrative · 0

CORRECTED DATA: SECTION D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER SHOULD BE (B)(4). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

Description of Event or Problem · 0

FURTHER REVIEW OF THE LOG FILES SHOWED A TIMESTAMP OF (B)(6) 2000 ALONG WITH SYSTEM CONTROLLER CLOCK RESET ALARMS THAT WERE ACTIVE UNTIL THE CLOCK WAS SET ON (B)(6) 2025. GIVEN THE CLOCK WILL RESET TO (B)(6) 2000, THE ONSET OF THE CLOCK RESET OCCURRED 49 DAYS PRIOR TO WHEN THE CLOCK WAS SET ON (B)(6) 2025. THIS PLACES THE ONSET OF THE SYSTEM CONTROLLER CLOCK RESET ALARMS AND CLOCK RESET TO (B)(6) 2025. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF LOW BATTERY ALARMS ON (B)(6) 2025. THE LOG FILE WAS NOT AVAILABLE FROM THE TIME OF THE PATIENT'S VISIT TO THE EMERGENCY ROOM ON (B)(6) 2025. THE CAUSE OF THE LOW BATTERY ALARMS WAS THE PATIENT TRAVELING AROUND TOWN AND DRAINING THEIR BATTERIES. THE PATIENT DID NOT HAVE THEIR SPARE BATTERIES WITH THEM. THE LOW BATTERY RESOLVED WHEN THE PUMP WAS CONNECTED TO THE POWER BASE UNIT WHILE CHARGING THEIR DRAINED BATTERIES IN THE EMERGENCY ROOM.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE LOG FILES WERE SUBMITTED FOR EVALUATION. THE EVENT LOG FILE CONTAINED DATA ASSOCIATED WITH CONTROLLER_CLOCK_CORRUPT ALARM FLAGS. IT WAS UNABLE TO BE DETERMINED WHAT THE CAUSE OF THIS ALARM WAS BASED ON THE DATA RECORDED. THESE ALARMS TYPICALLY OCCUR WITH A COMPLETE POWER LOSS, NO EXTERNAL POWER WITH A FULLY DEPLETED EMERGENCY BACKUP BATTERY (EBB). THE DATA INDICATED THAT THE PATIENT SLEPT ON BATTERY POWER. A CLOCK_TIME_CHANGED EVENT WAS RECORDED ON 08APR2025. THERE WERE ALSO LOW_PUMP_CURRENT EVENTS RECORDED. THESE EVENTS WERE OCCURRING FREQUENTLY BUT WERE NOT ASSOCIATED WITH AN ALARM. TECHNICAL SERVICES STATED THAT IT MAY BE NECESSARY TO PERFORM A PUMP RESET TO RESOLVE THIS FAULT. THE PATIENT HAD A HISTORY OF LOW BATTERY ALARM WHICH POSSIBLY COULD BE THE CAUSE OF THE LOW PUMP CURRENT. THERE WERE NO PATIENT SYMPTOMS, THE PATIENT WAS OUTSIDE WHEN THEY REALIZED THE BATTERY WAS BEEPING WITHOUT BEING THEIR EXTRA SYSTEM CONTROLLER. THE CAUSE OF THE SYSTEM CONTROLLER CLOCK CORRUPT EVENT WAS UNKNOWN. THERE WAS A PLAN FOR A SYSTEM CONTROLLER EXCHANGE AS SOON AS THE INTERNATIONAL NORMALIZED RATIO (INR) WAS ON THERAPEUTIC LEVEL. THE SYSTEM CONTROLLER WOULD BE RETURNED AFTER THE EXCHANGE PLANNED FOR 06MAY2025. THE LOG FILES WERE REVIEWED AGAIN AND FOUND MORE LOW PUMP CURRENT FAULTS THROUGHOUT THE HISTORY. IT WAS SUGGESTED IF THE PATIENT WAS STABLE THAT THE PUMP BE POWER CYCLED BY DISCONNECTING THE DRIVELINE. THERE WERE NO OTHER UNUSUAL EVENTS SEEN IN THE LOG FILES. THE SYSTEM CONTROLLER WAS THEN EXCHANGED. THE LOG FILES WERE REVIEWED AND ONLY SHOWED A COUPLE LINES OF DATA FOLLOWING THE SYSTEM CONTROLLER EXCHANGE. THERE WERE NO OTHER UNUSUAL EVENTS SEEN IN THE LOG FILE. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED AND WOULD BE RETURNED. THE SYSTEM CONTROLLER EXCHANGE RESOLVED THE LOW CURRENT FAULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
787183	THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER	VENTRICULAR (ASSIST) BYPASS	DSQ	THORATEC CORPORATION	106531US	8566344	00813024013235

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR	Male