HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2018-06841
- Event Type
- Death
- Date Received
- November 29, 2018
- Date of Event
- November 13, 2018
- Report Date
- October 31, 2019
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707002639
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: THE HVAD PUMP WAS RETURNED FOR EVALUATION. THE CONTROLLER AND FIVE BATTERIES (WERE NOT RETURNED FOR EVALUATION. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING, AND DIMENSIONAL VERIFICATION. INTERNAL PATHOLOGICAL REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. REVIEW OF THE ALARM LOG FILE REVEALED SEVEN CRITICAL BATTERY ALARMS LOGGED BETWEEN (B)(6) 2018 AND (B)(6) 2018 INVOLVING ALL THE BATTERIES DUE TO THEM DEPLETING BELOW 10% RELATIVE STATE OF CHARGE (RSOC). ADDITIONALLY, LOG FILE ANALYSIS REVEALED 72 CRITICAL BATTERY ALARMS AND 26 CONTROLLER FAULT ALARMS LOGGED STARTING (B)(6) 2018 AT 03:17:12. THE CRITICAL BATTERY ALARMS WERE THE RESULT OF THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10% RELATIVE STATE OF CHARGE (RSOC). A CONTROLLER FAULT ALARM WILL OCCUR IF THE BATTERY IS APPROACHING 0% RSOC. LOG FILE ANALYSIS REVEALED THAT, AT THE TIME OF THE FIRST CRITICAL BATTERY ALARM, BAT307884 WAS CONNECTED TO POWER PORT 1 WITH 9% RSOC AND BAT305166 WAS CONNECTED TO POWER PORT 2 WITH 20% RSOC. BOTH BATTERIES WERE THEN ALLOWED TO DEPLETE COMPLETELY. THE DEPLETED BATTERIES WERE NOT EXCHANGED, RESULTING IN A LOSS OF POWER TO THE CONTROLLER AT 05:47:20. 23 CONTROLLER POWER UP EVENTS WERE LOGGED STARTING ON (B)(6) 2018 AT 07:14:01. THE CONTROLLER WAS POWERED UP WITH CHARGED BATTERIES ON (B)(6) 2018 AT 16:42:44. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY, CONTROLLER FAULT ALARMS, AND LOSS OF POWER CAN BE ATTRIBUTED TO THE PATIENT ALLOWING BATTERIES TO DEPLETING BELOW 10%. THE BATTERIES LIKELY RECOVERED ENOUGH CHARGE TO START THE CONTROLLER AGAIN, BUT QUICKLY DEPLETED, CAUSING ADDITIONAL CONTROLLER POWER UP EVENTS. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. IN THIS CASE, THE PATIENT HAS HAD A HISTORY OF ALCOHOLISM AND HAS HAD PREVIOUS DOUBLE DISCONNECT EVENTS THAT LED TO SIGNIFICANT PUMP-OFF TIME AND SUBSEQUENT HOSPITALIZATION. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL PRODUCTS: SERIAL #: (B)(4), PATIENT CODE(S): C50759, SERIAL #: (B)(4), PATIENT CODE(S): C50759. SERIAL #: (B)(4), PATIENT CODE(S): C50759, SERIAL #: (B)(4), PATIENT CODE(S): C50759, SERIAL #: (B)(4), PATIENT CODE(S): C50759, SERIAL #: (B)(4), PATIENT CODE(S): C50759. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CORRECTIONS: PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS RETURNED FOR EVALUATION. THE CONTROLLER AND FIVE BATTERIES (B)(4) WERE NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING, AND DIMENSIONAL VERIFICATION. INTERNAL PATHOLOGICAL REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. REVIEW OF THE ALARM LOG FILE REVEALED 7 CRITICAL BATTERY ALARMS LOGGED BETWEEN (B)(6) 2018 INVOLVING (B)(4) DUE TO THE BATTERIES DEPLETING BELOW 10% RELATIVE STATE OF CHARGE (RSOC). ADDITIONALLY, LOG FILE ANALYSIS REVEALED 72 CRITICAL BATTERY ALARMS AND 26 CONTROLLER FAULT ALARMS LOGGED STARTING (B)(6) 2018 AT 03:17:12. THE CRITICAL BATTERY ALARMS WERE THE RESULT OF THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10% RELATIVE STATE OF CHARGE (RSOC). A CONTROLLER FAULT ALARM WILL OCCUR IF THE BATTERY IS APPROACHING 0% RSOC. LOG FILE ANALYSIS REVEALED THAT, AT THE TIME OF THE FIRST CRITICAL BATTERY ALARM, (B)(4) WAS CONNECTED TO POWER PORT 1 WITH 9% RSOC AND (B)(4) WAS CONNECTED TO POWER PORT 2 WITH 20% RSOC. BOTH BATTERIES WERE THEN ALLOWED TO DEPLETE COMPLETELY. THE DEPLETED BATTERIES WERE NOT EXCHANGED, RESULTING IN A LOSS OF POWER TO THE CONTROLLER AT 05:47:20. FOUR (4) CONTROLLER POWER UP EVENTS WERE LOGGED ON (B)(6) 2018 AT 02:19:51, ON (B)(6) 2018 AT 05:12:23 AND 05:17:17 AND ON (B)(6) 2018 AT 10:37:46. ADDITIONALLY, 23 CONTROLLER POWER UP EVENTS WERE LOGGED STARTING ON (B)(6) 2018 AT 07:14:01. THE CONTROLLER WAS POWERED UP WITH CHARGED BATTERIES ON (B)(6) 2018 AT 16:42:44. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY, CONTROLLER FAULT ALARMS, AND LOSS OF POWER ON (B)(6) 2018, CAN BE ATTRIBUTED TO THE PATIENT ALLOWING BATTERIES TO DEPLETING BELOW 10%. THE BATTERIES LIKELY RECOVERED ENOUGH CHARGE TO START THE CONTROLLER AGAIN, BUT QUICKLY DEPLETED, CAUSING ADDITIONAL CONTROLLER POWER UP EVENTS. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER ON (B)(6) 2018, CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON BOTH POWER SOURCES. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. ADDITIONAL PRODUCTS: DEVICE IDENTIFICATION: SERIAL #: (B)(4). DEVICE EVALUATED BY MFR: YES. ADVERSE EVENT PROBLEM: FDA CONCLUSION CODE(S): 19. DEVICE IDENTIFICATION: SERIAL #: (B)(4). DEVICE EVALUATED BY MFR: YES. ADVERSE EVENT PROBLEM: FDA CONCLUSION CODE(S): 19. DEVICE IDENTIFICATION: SERIAL #: (B)(4). DEVICE EVALUATED BY MFR: YES. ADVERSE EVENT PROBLEM: FDA CONCLUSION CODE(S): 19. DEVICE IDENTIFICATION: SERIAL #: (B)(4). DEVICE EVALUATED BY MFR: YES. ADVERSE EVENT PROBLEM: FDA CONCLUSION CODE(S): 19. DEVICE IDENTIFICATION: SERIAL #: (B)(4). DEVICE EVALUATED BY MFR: YES. ADVERSE EVENT PROBLEM: FDA CONCLUSION CODE(S): 19. DEVICE IDENTIFICATION: SERIAL #: (B)(4). DEVICE EVALUATED BY MFR: YES. ADVERSE EVENT PROBLEM: FDA CONCLUSION CODE(S): 19. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS FURTHER REPORTED THAT AT THE TIME OF AUTOPSY, AN ACUTE SUBDURAL HEMORRHAGE DUE TO THE PATIENT'S ANTICOAGULATION THERAPY WAS FOUND.
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. CONCOMITANT MEDICAL PRODUCTS: 693565 - LEAD, IMPLANTED: (B)(6) 2013. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0: CON311620 / MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 2018-08-31, UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-08-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BAT307884 / MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 2016-11-30, UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BAT307852 / MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 2016-11-30, UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BAT313675 / MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 2017-01-31, UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-01-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BAT307888/ MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 2016-11-30, UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BAT305166/ MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 2016-10-31, UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-10-31. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT WAS FOUND UNRESPONSIVE BY A FRIEND, AND WAS UNABLE TO BE RESUSCITATED BY EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT WAS FOUND WITH THE CONTROLLER ALARMING WITH NO INDICATION THAT POWER WAS BEING PROVIDED TO THE PUMP. IT WAS FURTHER REPORTED THAT THE PATIENT HAD STARTED TO LET THEIR BATTERIES DRAIN BELOW 10% SINCE (B)(6) 2018, AND CONTROLLER FAULT ALARMS WERE TRIGGERED DUE THE LOW POWER CONDITION. THE VENTRICULAR ASSIST DEVICE (VAD), BATTERIES AND CONTROLLER WERE REMOVED FROM SERVICE. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 953717 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707002639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Death | DDBB1D1 - DEFIBRILATOR, 5076-52 - LEAD.| DDBB1D1 - DEFIBRILATOR, 5076-52 - LEAD |