HEARTMATE 3 LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2023-08870
- Event Type
- Malfunction
- Date Received
- January 8, 2024
- Date of Event
- September 14, 2023
- Report Date
- January 31, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED CONTROLLER CLOCK CORRUPT ALARMS, AS WELL AS A RESET OF THE PUMP CLOCK, INDICATING A TOTAL LOSS OF POWER TO THE SYSTEM CONTROLLER WITH AN ASSOCIATED PUMP STOP. ACCORDING TO THE ACCOUNT, THE PATIENT GOT STUCK IN TRAFFIC AND THEIR BATTERIES DEPLETED. A SPECIFIC DURATION OF TIME FOR WHICH THE PUMP WAS STOPPED COULD NOT CONCLUSIVELY BE DETERMINED. THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) PERIODIC LOG FILE CONTAINED APPROXIMATELY 3 MONTHS OF DATA WITH THE PUMP CLOCK SET TO THE DEFAULT TIMESTAMP, INDICATING THAT A PUMP STOP HAD OCCURRED. HOWEVER, A SPECIFIC CAUSE FOR THE CLOCK RESET COULD NOT BE DETERMINED THROUGH THIS EVALUATION AS THE ONSET OF THE EVENT WAS OVERWRITTEN BY NEWER DATA, PER DESIGN. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED. IT WAS REPORTED THAT THE PATIENT HAD TRAVELED WITHOUT THEIR SECOND SET OF 14 VOLT (V) BATTERIES AND ON THEIR WAY HOME, THERE WAS A CAR PILEUP ON THE ROAD AND THEIR 14 V BATTERIES WERE DEPLETED AND THE SYSTEM CONTROLLER'S BACKUP BATTERY (EBB) WAS ACTIVATED. THE PATIENT REPORTED RUNNING ON THEIR EBB FOR ABOUT ONE HOUR. AS SOON AS THE PATIENT GOT HOME, THEY IMMEDIATELY EXCHANGED THEIR DEPLETED BATTERIES FOR FULLY CHARGED BATTERIES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS, BUT IT WAS REPORTED THAT THE SYSTEM CONTROLLER DATE AND TIME HAD TO BE RESET. THE PATIENT WAS IN GREAT HEMODYNAMIC CONDITION, AND NO COMPLICATIONS WERE OBSERVED. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-021010 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), AND THE HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 2 OF THE IFU, ¿SYSTEM OPERATIONS¿, STATES THAT THE 11 VOLT LITHIUM-ION BACKUP BATTERY SHOULD BE USED ONLY FOR TEMPORARY SUPPORT DURING A POWER-LOSS EMERGENCY. THE 11 VOLT LITHIUM-ION BACKUP BATTERY INSIDE THE HEARTMATE 3 SYSTEM CONTROLLER PROVIDES ENOUGH POWER TO RUN THE IMPLANTED HEARTMATE 3 PUMP FOR AT LEAST 15 MINUTES IF THE MAIN POWER SOURCE (EITHER THE POWER MODULE, MOBILE POWER UNIT, OR TWO HEARTMATE 14 VOLT LITHIUM-ION BATTERIES) IS DISCONNECTED OR FAILS. INAPPROPRIATE USE OF THE 11 VOLT LITHIUM-ION BACKUP BATTERY MAY RESULT IN DIMINISHED RUN TIME DURING A POWER-LOSS EMERGENCY. ADDITIONALLY, EVERY HEARTMATE 14 VOLT LITHIUM-ION BATTERY ALSO HAS ITS OWN ON-BATTERY GAUGE. IT SHOWS THE POWER LEVEL FOR THAT BATTERY. 4 GREEN BARS = 75¿100% OF BATTERY POWER REMAINS. 3 GREEN BARS = 50¿75% OF BATTERY POWER REMAINS. 2 GREEN BARS = 25¿50% OF BATTERY POWER REMAINS. 1 GREEN BAR = LESS THAN 25% OF BATTERY POWER REMAINS. SECTION 4 OF THE IFU, "SYSTEM MONITOR", STATES THAT THAT THE SYSTEM CONTROLLER CAN STORE 256 EVENTS. WHEN THE MEMORY IS FULL, THE OLDEST EVENTS ARE DELETED AS NEW ONES ARE SAVED. SECTION 3 OF THE PATIENT HANDBOOK, ¿POWERING THE SYSTEM¿, DETAILS HOW TO CHECK A BATTERY'S CHARGE LEVEL, REPLACING LOW BATTERIES WITH FULLY-CHARGED BATTERIES, AND SWITCHING POWER SOURCES. TWO, NEW, FULLY CHARGED LI-ION BATTERIES PROVIDE 17 HOURS OF SUPPORT. BATTERIES LAST FOR LESS TIME IF THE USER IS ACTIVE OR EMOTIONALLY STRESSED. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE IFU CAUTION 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. SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION, AS WELL AS THE PROPER ACTIONS ASSOCIATED WITH THEM. THESE DOCUMENTS ALSO WARN OF EVENTS THAT MAY CAUSE THE PUMP TO STOP AND HOW TO PREVENT PUMP STOPS FROM OCCURRING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO REPORT THE INVESTIGATION FINDINGS.
IT WAS REPORTED THAT THE PATIENT TRAVELLED WITHOUT THEIR SECOND SET OF BATTERIES. ON THEIR WAY HOME, THE PATIENT GOT STUCK IN TRAFFIC AND THEIR BATTERIES DEPLETED, WHICH LED THE EMERGENCY BACKUP BATTERY (EBB) TO APPROPRIATELY ENGAGE. THE PATIENT CLAIMED THEY WERE ON THE EBB FOR +/- 1 HOUR. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SIDE EFFECTS AS A RESULT OF THIS EVENT. THE SYSTEM CONTROLLER CLOCK HAD TO BE RESET, AS THE LOG FILES REVEALED MULTIPLE CONTROLLER CLOCK CORRUPT MESSAGES AND THE CONTROLLER AT ONE POINT HAD LOST POWER, BUT THE PUMP DID NOT TURN OFF. LOG FILE ANALYSIS NOTED THAT THE DATA IN THE PUMP LOG FILES WAS CAPTURED WITH THE DEFAULT TIMESTAMP OF 2000, SUGGESTING THAT THE PUMP HAD LOST POWER AND THE PUMP¿S CLOCK HAD ALSO RESET, WHICH IS INDICATIVE OF A PUMP STOP. ADDITIONALLY, A NO EXTERNAL POWER ALARM WAS OBSERVED WHILE THE CONTROLLER WAS CONNECTED TO THE MOBILE POWER UNIT (MPU). IT WAS LATER REPORTED THAT THE NO EXTERNAL POWER WAS DUE TO A LOSS OF AC POWER TO THE PATIENT'S RESIDENCE, AS A RESULT OF LOAD SHEDDING. THE ACCOUNT ALSO REPORTED THAT THE PATIENT DID NOT HAVE A PUMP STOP. THE PATIENT WAS REPORTEDLY HEMODYNAMICALLY STABLE AND EXPERIENCED NO ADVERSE CONSEQUENCES.
RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2023-08871. IT WAS REPORTED THAT THE PATIENT TRAVELLED WITHOUT THEIR SECOND SET OF BATTERIES. ON THEIR WAY HOME, THE PATIENT GOT STUCK IN TRAFFIC AND THEIR BATTERIES DEPLETED, WHICH LED THE EMERGENCY BACKUP BATTERY (EBB) TO APPROPRIATELY ENGAGE. THE PATIENT CLAIMED THEY WERE ON THE EBB FOR +/- 1 HOUR. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SIDE EFFECTS AS A RESULT OF THIS EVENT. THE SYSTEM CONTROLLER CLOCK HAD TO BE RESET, AS THE LOG FILES REVEALED MULTIPLE CONTROLLER CLOCK CORRUPT MESSAGES AND THE CONTROLLER AT ONE POINT HAD LOST POWER, BUT THE PUMP DID NOT TURN OFF. LOG FILE INVESTIGATION FOUND A NO EXTERNAL POWER EVENT ON THE MONILE POWER UNIT (MPU) WHICH OCCURRED DUE TO AN ACUTE LOSS OF POWER, BUT THERE WAS NO ASSOCIATED PUMP STOP. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675609 | HEARTMATE 3 LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524INT | 7404826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male |