THORATEC® HEARTMATE II®, SYSTEM CONTROLLER
Report
- Report Number
- 2916596-2024-03286
- Event Type
- Malfunction
- Date Received
- June 11, 2024
- Date of Event
- May 6, 2024
- Report Date
- September 27, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024011286
- PMA / PMN Number
- P060040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION H6 (MEDICAL DEVICE PROBLEM CODE): CORRECTION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A COMMUNICATION ISSUE BETWEEN THE CONTROLLER AND THE SYSTEM MONITOR WAS NOT CONFIRMED. DATA FROM THE REPORTED EVENT DATE OF 21MAY2024 IN THE SUBMITTED LOG FILE (093646) WAS REVIEWED. THE SYSTEM CONTROLLER WAS CONNECTED TO THE POWER MODULE ON (B)(6) 2024 AT 23:33:35. THE SPEED REMAINED AT 0 RPM WHILE THE DRIVELINE FAULT ALARMS CONTINUED FROM THE PRIMARY CONTROLLER. THE YELLOW WRENCH ALARM WAS ACTIVE DURING THIS ALARM AS WELL. PHASE 2 WAS SIGNIFICANTLY LOWER THAN PHASES 1 AND 3. THE ALARM WAS AUTOMATICALLY SILENCED WITH 7.29 SOFTWARE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE SYSTEM CONTROLLER, SERIAL (B)(6) , WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION INDICATED THAT WHEN THE SYSTEM CONTROLLER WAS EXCHANGED TO AND THE PUMP HAD RESTARTED, THE SYSTEM MONITOR WAS NO LONGER ABLE TO PULL DATA FROM THE CONTROLLER. THE CONTROLLER WAS CONSEQUENTLY EXCHANGED. THE COMMUNICATION BETWEEN THE CONTROLLER AND MONITOR DEPENDS ON THE TRANSMISSION AND RECEIVING WIRES IN THE WHITE POWER CABLE, BUT THERE WAS NO REPORTED DAMAGE TO THE POWER CABLE. THERE WERE NO PICTURES OR ADDITIONAL DOCUMENTS PROVIDED. THE PUMP INVESTIGATION CONFIRMED A SHORT TO SHIELD IN THE BLACK WIRE OF THE PERCUTANEOUSLY LEAD, RESULTING IN THE SPEED DROPS AND PUMP STOPS. THE DRIVELINE FAULT ALARM WAS NOT CORRELATED TO AN ISSUE WITH THE SYSTEM CONTROLLER. THE REPORTED EVENT OF A COMMUNICATION ISSUE WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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 II INSTRUCTIONS FOR USE (REV. C) SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK (REV. C) SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL ALARMS, INCLUDING DRIVELINE FAULT ALARMS. HEARTMATE II INSTRUCTIONS FOR USE (REV. C) SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE II PATIENT HANDBOOK (REV. C) SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER CONNECTORS AND CABLES. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
SECTION D4: DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
AFTER THE SECOND CONTROLLER EXCHANGE, PRIOR TO THE DRIVELINE REPAIR, THE PATIENT WAS PLACED ON AN UNGROUNDED CABLE. ADDITIONALLY, THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR NOTED THAT TWO SYSTEM CONTROLLERS HAD GONE INTO BACKUP MODE PRIOR TO THE DRIVELINE REPAIR.
IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR RED HEART HAZARD ALARMS. THE PUMP WAS NOT RUNNING AND THERE WAS NO HUM ON AUSCULTATION. THE PATIENT WAS ALERT BUT UNABLE TO ANSWER QUESTIONS APPROPRIATELY. THE PATIENT'S BASELINE FOR VERBAL RESPONSES VARIED DUE TO A HISTORY OF STROKES. THE LOG FILES SUBMITTED FIRST CAPTURED SPEED REDUCTION EVENTS AND PUMP STOP EVENTS AT (B)(6) 2024 11:42 WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU). THE RECORDED DATA INDICATED THAT THE PUMP STOPS OCCURRED LATER WHILE THE PATIENT WAS CONNECTED TO THE MOBILE POWER UNIT (MPU) AND THEN BATTERY POWER ON (B)(6) 2024 AT 21:52. THE PUMP SPEED THEN REMAINED AT 0 ROTATIONS PER MINUTE. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2024 AT 23:24. THIS WAS INDICATIVE OF POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD. THE PATIENT HAD A SEVERE TWISTING OF THE DRIVELINE NEAR THE EXIT SITE WHICH MAY HAVE CAUSED CONDUCTOR FATIGUE AND DAMAGE. OF NOTE, THE PATIENT HAD PREVIOUSLY HAD TWISTING OF THE DRIVELINE AND A PUMP EXCHANGE IN THE PAST SO THIS EVENT HAS OCCURRED ON A NEW PUMP. THE PATIENT WAS GIVEN HEPARIN, AND THE SYSTEM CONTROLLER WAS EXCHANGED TO THE BACKUP SYSTEM CONTROLLER. THE LIGHTS AND ALARMS WERE IDENTICAL FOR ABOUT 10 MINUTES, THEN AT 12:50 A.M. THE GREEN PUMP RUNNING SYMBOL WAS ON, RED HEART WAS OFF, AND YELLOW WRENCH WAS ON. THE PUMP WAS RUNNING, AND A HUM WAS HEARD ON AUSCULTATION. THE PATIENT WAS PULSATILE AND THEIR AUTOMATIC BLOOD PRESSURES READ 70/30 MILLIMETERS OF MERCURY (MMHG). A DOPPLER MEAN ARTERIAL PRESSURE (MAP) WAS ATTEMPTED AND THE CLINICIAN FELT THAT THE SYSTOLIC BLOOD PRESSURES WAS AROUND 110 MMHG. THE PATIENT WAS AWAKE, ALERT, AND ORIENTED AT THAT TIME AND SILENCED THE ALARMS WITH STAFF PRESENT. EVENT LOG FILES WERE TAKEN FROM THE PRIMARY SYSTEM CONTROLLER. ONCE THE PUMP RESTARTED ON THE NEW CONTROLLER, THE SYSTEM MONITOR WAS NO LONGER PULLING DATA FROM THE CONTROLLER. THE ADVISORY ALARM READ "CONTROLLER FAULT" AND CONTINUED WITH THAT MESSAGE. THE EVENT LOG FILES CAPTURED A DRIVELINE FAULT ALARM THAT BECAME ACTIVE ON (B)(6) 2024 AT 13:42 WHICH WOULD HAVE GENERATED A YELLOW WRENCH ALARM. THE DATA INDICATED THAT THIS EVENT WAS LIKELY DUE TO ONE OF THE CONDUCTORS WITHIN THE DRIVELINE BECOMING FRACTURED OR SEVERED. AN X-RAY WAS PERFORMED AND CAPTURED SOME INCONSISTENCY THROUGHOUT THE EXTERNAL AREA OF THE DRIVELINE. THE X-RAY SHOWED SEVERE TWISTING FROM THE EXTERNAL BEND RELIEF TO THE EXIT SITE. THE DRIVELINE FAULT ALARM REMAINED ACTIVE ON THE NEW SYSTEM CONTROLLER WHICH INDICATED THAT THERE WAS A DAMAGED CONDUCTOR WITHIN THE DRIVELINE. PHASE TO PHASE SYMPTOMS WERE ALSO OBSERVED WHICH WAS LIKELY DUE TO DAMAGE TO MORE THAN ONE CONDUCTOR. IT WAS RECOMMENDED TO IMMOBILIZE THE PERCUTANEOUS LEAD TO PREVENT ANY FURTHER INTERRUPTIONS IN SUPPORT. IT WAS ADDITIONALLY NOTED THAT THE PATIENT WAS PLACED ON A LOANER SYSTEM CONTROLLER DUE TO THE BACKUP SYSTEM CONTROLLER BEING UNABLE TO TRANSMIT DATA. ON 23MAY2024 ADDITIONAL LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED ALARMS ASSOCIATED WITH A CONTROLLER SWAP TO ANOTHER BACKUP CONTROLLER ON (B)(6) 2024. FOLLOWING THESE INITIAL ALARMS THE ONSET OF DRIVELINE FAULTS WAS RECORDED. A DRIVELINE REPAIR WAS COMPLETED ON (B)(6) 2024. THE DRIVELINE WAS BADLY TANGLED BUT WAS STRAIGHTENED OUT DURING THE REPAIR. IT WAS NOTED THAT THE SILASTIC LAYER WAS TWISTED AND A HAD A FEW KINKS NEAR THE SYSTEM CONTROLLER. THE BLACK WIRE WAS SUSPECTED SO IT WAS SPLICED FIRST, AND THE DRIVELINE WAS SWAPPED WITHOUT ISSUE. ON 24MAY2024 ADDITIONAL LOG FILES WERE SUBMITTED AFTER THE PERCUTANEOUS LEAD REPAIR ATTEMPT ON 23MAY2024 AND CAPTURED NO UNUSUAL ALARMS OR EVENTS RECORDED SINCE THE PERCUTANEOUS LEAD REPAIR WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1294931 | THORATEC® HEARTMATE II®, SYSTEM CONTROLLER | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106762 | 00813024011286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Male |