HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Report
- Report Number
- 3007042319-2019-12243
- Event Type
- Death
- Date Received
- October 24, 2019
- Date of Event
- October 3, 2019
- Report Date
- October 27, 2021
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707002639
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-0946-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL PRODUCTS:(B)(6) H6: PATIENT IME CODE(S): E0611 H6: IMF CODE(S): F02 H6: IMG CODE(S): (B)(6) H6: PATIENT IME CODE(S): E0611 H6: IMF CODE(S): F02 H6: IMG CODE(S): (B)(6) H6: PATIENT IME CODE(S): E0611 H6: IMF CODE(S): F02 H6: IMG CODE(S): (B)(6) H6: PATIENT IME CODE(S): E0611 H6: IMF CODE(S): F02 H6: IMG CODE(S): (B)(6) H6: PATIENT IME CODE(S): E0611 H6: IMF CODE(S): F02 H6: IMG CODE(S): (B)(6) H6: PATIENT IME CODE(S): E0611 H6: IMF CODE(S): F02 H6: IMG CODE(S): (B)(6) H6: PATIENT IME CODE(S): E0611 H6: IMF CODE(S): F02 H6: IMG CODE(S): (B)(6). THE DISPOSITION OF THE PRODUCTS HAS BEEN REQUESTED. IF THE PRODUCTS ARE RECEIVED FOR ANALYSIS, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. THE PRODUCT EVENT SUMMARY HAS BEEN UPDATED WITH THE FOLLOWING: PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) (B)(6) IS PART OF FCA CVG-21-Q3-21. CAPA PR00502194 IS INVESTIGATING PUMP FAILURES TO RESTART. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: HVAD PUMP, TWO CONTROLLERS AND FIVE BATTERIES WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE PRIMARY CONTROLLER LOG FILES ASSOCIATED WITH ONE OF THE CONTROLLERS REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2019, AT 15:18:09. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT AN ACTIVE ADAPTER WAS CONNECTED TO POWER PORT ONE AND BATTERY WAS CONNECTED TO POWER PORT TWO WITH 71% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT THE BATTERY WAS CONNECTED TO POWER PORT ONE AND BATTERY WAS CONNECTED TO POWER PORT TWO. THE CONTROLLER WAS WITHOUT POWER FOR 12 SECONDS. A VAD STOPPED ALARM WAS THEN LOGGED AT 15:18:56 INDICATING THAT THE MOTOR FAILED TO RESTART ON MULTIPLE ATTEMPTS AND WAS FOLLOWED BY SEVERAL MORE VAD STOPPED ALARMS AND CONTROLLER POWER UP EVENTS. SEVERAL VAD DISCONNECT ALARMS WERE RECORDED ON THE CONTROLLER ON (B)(6) 2019. AN ANALYSIS OF THE ALARM FILE REVEALED THAT THE VAD DISCONNECT ALARMS WERE MOST LIKELY FALSE ALARMS, GIVEN THAT THE SPEED RECORDED AT THE ONSET OF THE ALARM WAS HIGHER THAN THE SET SPEED. THIS INDICATES THAT A POSSIBLE LOSS OF SYNCHRONIZATION OF COMMUTATION OCCURRED. COMMUTATION IS THE PROCESS OF SWITCHING WINDING CURRENT TO GENERATE MOTION. IF THE PUMP ROTATIONAL SPEED DRIFTS HIGHER THAN THE SPEED SET-POINT, THE MOTOR VOLTAGE WILL DECREASE TO ACHIEVE THE DESIRED SPEED. HOWEVER, IF THERE IS NO CHANGE TO THE SPEED (SPEED READING REMAINS FROZEN), THE VOLTAGE WILL CONTINUE TO DECREASE TO ZERO. THIS LIKELY CAUSED THE CURRENT TO DECREASE TO ZERO, TRIGGERING A VAD DISCONNECT ALARM, EVEN IF THE DRIVELINE WAS STILL PHYSICALLY CONNECTED TO THE CONTROLLER. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILE REVEALED MULTIPLE POWER DISCONNECT ALARMS WERE LOGGED ON THE CONTROLLER INVOLVING THREE BATTERIES. DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING AN OVERCURRENT ALERT. THE EVENT LOG RECORDED A HIGH POWER CONSUMPTION DURING THE MOTOR STARTS, WHICH REQUIRED MORE CURRENT FROM THE BATTERIES. THE BATTERY WAS MOST LIKELY PHYSICALLY DISCONNECTED BY T HE PATIENT SHORTLY AFTER, CAUSING THE CONTROLLER TO LOG THIS EVENT AS A POWER DISCONNECT ALARM. FURTHERMORE, SEVERAL CONTROLLER FAULT ALARMS WERE LOGGED ON (B)(6) 2020 SINCE 17:50:38 DUE TO THE INCREASED CURRENT REQUIRED FROM THE BATTERIES. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH ONE OF THE CONTROLLER REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2019 AT 16:29:41, LIKELY DURING A CONTROLLER EXCHANGE. SEVERAL VAD DISCONNECT ALARMS WERE RECORDED ON THE CONTROLLER ON (B)(6) /2019. AN ANALYSIS OF THE ALARM FILE REVEALED THAT THESE VAD DISCONNECT ALARMS WERE ALSO LIKELY FALSE ALARMS, GIVEN THAT THE SPEED RECORDED AT THE ONSET OF THE ALARM WAS HIGHER THAN THE SET SPEED, INDICATIVE OF A POSSIBLE LOSS OF SYNCHRONIZATION OF COMMUTATION. A VAD STOPPED ALARM WAS THEN LOGGED AT 16:31:32 INDICATING THAT THE MOTOR FAILED TO RESTART ON MULTIPLE ATTEMPTS FOLLOWED BY MORE VAD DISCONNECT ALARMS AND CONTROLLER POWER UP EVENTS LIKELY DUE TO TROUBLESHOOTING OF THE ALARMS. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILE REVEALED MULTIPLE POWER DISCONNECT ALARMS WERE LOGGED ON CONTROLLER INVOLVING TWO BATTERIES. DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING AN OVERCURRENT ALERT. THE EVENT LOG RECORDED A HIGH POWER CONSUMPTION DURING THE MOTOR STARTS, WHICH REQUIRED MORE CURRENT FROM THE BATTERY. THE BATTERY WAS MOST LIKELY PHYSICALLY DISCONNECTED BY THE PATIENT SHORTLY AFTER, CAUSING THE CONTROLLER TO LOG THIS EVENT AS A POWER DISCONNECT ALARM. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A LOSS OF COMMUTATION, LEADING TO FALSE VAD DISCONNECT ALARMS. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON BOTH POWER SOURCES. A POSSIBLE ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARMS MAY BE ATTRIBUTED, BUT NOT LIMITED, TO A PHYSICAL DISCONNECTION OF THE POWER SOURCE. THE MOST LIKELY ROOT CAUSE OF THE VAD STOPPED ALARMS CAN BE ATTRIBUTED TO FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. INTERNAL INVESTIGATIONS WERE CREATED TO INVESTIGATE FAILURES OF THE PUMP TO RESTART AT THE SYSTEM LEVEL (INTERACTION BETWEEN THE PUMP AND PERIPHERAL DEVICES). BASED ON AN EXTENSIVE INVESTIGATION CONDUCTED UNDER THIS INVESTIGATION, THE LIKELY CONTRIBUTING CAUSE FOR FAILURE TO RESTART WAS THE INABILITY OF THE PUMP-START ALGORITHM TO PROVIDE SUFFICIENT TORQUE TO OVERCOME ABNORMALLY HIGH MECHANICAL RESISTANCE CAUSED BY UNKNOWN CONDITIONS THAT EXISTED PRIOR TO THE FAILED RESTART ATTEMPT. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. CONTINUATION OF D11: D4: SERIAL # (B)(6) H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 120 H6: FDA CONCLUSION CODE(S): 4307 D4: SERIAL # CON404795 H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 120 H6: FDA CONCLUSION CODE(S): 4307 D4: SERIAL # (B)(6) H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL # (B)(6) H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL # (B)(6) H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S):67 D4: SERIAL # (B)(6) H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S):67 D4: SERIAL # (B)(6) H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S):67 INVESTIGATION OF THIS EVENT IS COMPLETED, AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED, AND A SUPPLEMENTAL WILL BE SUBMITTED. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. NEWLY RECEIVED INFORMATION PROVIDED RELEVANT HISTORY AND LAB VALUES; B6 AND B7 UPDATED. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE RECALL NUMBER. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION AND INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) , TWO CONTROLLERS , AND FIVE BATTERIES WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH (B)(6) REVEALED A CONTROLLER POWER UP EVENT ON 03-OCT-2019, AT 15:18:09. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT AN ACTIVE ADAPTER WAS CONNECTED TO POWER PORT ONE AND (B)(6) WAS CONNECTED TO POWER PORT TWO WITH 71% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE AND (B)(6) WAS CONNECTED TO POWER PORT TWO . THE CONTROLLER WAS WITHOUT POWER FOR 12 SECONDS. A VAD STOPPED ALARM WAS THEN LOGGED AT 15:18:56 INDICATING THAT THE MOTOR FAILED TO RESTART ON MULTIPLE ATTEMPTS AND WAS FOLLOWED BY SEVERAL ADDITIONAL VAD STOPPED ALARMS AND CONTROLLER POWER UP EVENTS. SEVERAL VAD DISCONNECT ALARMS WERE RECORDED ON (B)(6) ON 03-OCT-2019. AN ANALYSIS OF THE ALARM FILE REVEALED THAT THE VAD DISCONNECT ALARMS WERE MOST LIKELY FALSE ALARMS, GIVEN THAT THE SPEED RE CORDED AT THE ONSET OF THE ALARM WAS HIGHER THAN THE SET SPEED. THIS INDICATES THAT A POSSIBLE LOSS OF SYNCHRONIZATION OF COMMUTATION OCCURRED. COMMUTATION IS THE PROCESS OF SWITCHING WINDING CURRENT TO GENERATE MOTION. IF THE VAD ROTATIONAL SPEED DRIFTS HIGHER TH AN THE SPEED SET-POINT, THE MOTOR VOLTAGE WILL DECREASE TO ACHIEVE THE DESIRED SPEED. HOWEVER, IF THERE IS NO CHANGE TO THE SPEED (SPEED READING REMAINS FROZEN), THE VOLTAGE WILL CONTINUE TO DECREASE TO ZERO. THIS LIKELY CAUSED THE CURRENT TO DECREASE TO ZERO, TRIGGERING A VAD DISCONNECT ALARM, EVEN IF THE DRIVELINE WAS STILL PHYSICALLY CONNECTED TO THE CONTROLLER. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILE REVEALED THAT MULTIPLE POWER DISCONNECT ALARMS WERE LOGGED ON (B)(6) INVOLVING (B)(6). DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING AN OVERCURRENT ALERT. THE EVENT LOG RECORDED A HIGH POWER CONSUMPTION DURING THE MOTOR STARTS, WHICH REQUIRED MORE CURRENT FROM THE BATTERIES. THE BATTERY WAS MOST LIKELY PHYSICALLY DISCONNECTED BY THE PATIENT SHORTLY AFTER, CAUSING THE CONTROLLER TO LOG THIS EVENT AS A POWER DISCONNECT ALARM. FURTHERMORE, SEVERAL CONTROLLER FAULT ALARMS WERE LOGGED ON 03-OCT-2020 SINCE 17:50:38 DUE TO THE INCREASED CURRENT REQUIRED FROM THE BATTERIES. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH (B)(6) REVEALED A CONTROLLER POWER UP EVENT ON 03-OCT-2019 AT 16:29:41, LIKELY DURING A CONTROLLER EXCHANGE. SEVERAL VAD DISCONNECT ALARMS WERE RECORDED ON (B)(6) ON 03-OCT-2019. AN ANALYSIS OF THE ALARM FILE REVEALED THAT THESE VAD DISCONNECT ALARMS WERE ALSO LIKELY FALSE ALARMS, GIVEN THAT THE SPEED RECORDED AT THE ONSET OF THE ALARM WAS HIGHER THAN THE SET SPEED, INDICATIVE OF A POSSIBLE LOSS OF SYNCHRONIZATION OF COMMUTATION. A VAD STOPPED ALARM WAS THEN LOGGED AT 16:31:32 INDICATING THAT THE MOTOR FAILED TO RESTART ON MULTIPLE ATTEMPTS, FOLLOWED BY MORE VAD DISCONNECT ALARMS AND CONTROLLER POWER UP EVENTS, LIKELY DUE TO TROUBLESHOOTING OF THE ALARMS. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILE REVEALED MULTIPLE POWER DISCONNECT ALARMS WERE LOGGED ON (B)(6) INVOLVING (B)(6). DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING AN OVER CURRENT ALERT. THE EVENT LOG RECORDED A HIGH POWER CONSUMPTION DURING THE MOTOR STARTS, WHICH REQUIRED MORE CURRENT FROM THE BATTERY. THE BATTERY WAS MOST LIKELY PHYSICALLY DISCONNECTED BY THE PATIENT SHORTLY AFTER, CAUSING THE CONTROLLER TO LOG THIS EVENT AS A POWER DISCONNECT ALARM. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A LOSS OF COMMUTATION, LEADING TO FALSE VAD DISCONNECT ALARMS. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON BOTH POWER SOURCES. A POSSIBLE ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARMS MAY BE ATTRIBUTED, BUT NOT LIMITED, TO A PHYSICAL DISCONNECTION OF THE POWER SOURCE. THE MOST LIKELY ROOT CAUSE OF THE VAD STOPPED ALARMS CAN BE ATTRIBUTED TO FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. AN INTERNAL INVESTIGATION IS EVALUATING EVENTS INVOLVING PUMP FAILURES TO RESTART. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15,B17 H6: FDA RESULTS CODE(S): C02, C19 H6: FDA CONCLUSION CODE(S): D02, D10 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15,B17 H6: FDA RESULTS CODE(S): C02 , C19 H6: FDA CONCLUSION CODE(S): D10, D15 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15,B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15,B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15,B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15,B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15,B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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 THE PATIENT EXPIRED FIVE DAYS AFTER THE VAD WAS TURNED OFF.
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: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: MODEL #: 1420-CONTROLLER / 1420-CONTROLLER / EXPIRATION DATE: 31-DEC-2019 SERIAL (B)(4) UDI #: (B)(4). NO . UNK. NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0. MODEL #: 1420 / CATALOG # 1420 / EXPIRATION DATE: 30-NOV-2019 SERIAL (B)(4) UDI #: (B)(4). NO. UNK. NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / CATALOG # 1650DE / EXPIRATION DATE: 31-AUG-2018 LOT BAT585134 UDI #: (B)(4). NO . UNK. NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / CATALOG # 1650DE / EXPIRATION DATE: 31-JAN-2019 LOT BAT595089 UDI #: (B)(4).: NO. UNK . (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / CATALOG # 1650DE / EXPIRATION DATE: 30-NOV-2018 LOT BAT590177 UDI #: (B)(4). (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL #: 1650DE / CATALOG # 1650DE / EXPIRATION DATE: 30-NOV-2018 LOT BAT590828 UDI #: (B)(4). NO. UNK. NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL #: 1650DE / CATALOG # 1650DE / EXPIRATION DATE: 30-NOV-2018 LOT BAT589501 UDI #: (B)(4). NO. NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT¿S PRIMARY CONTROLLER EXHIBITED UNEXPECTED LOSSES OF POWER WHICH TRIGGERED MULTIPLE VENTRICULAR ASSIST DEVICE (VAD) DISCONNECT ALARMS, CONTROLLER FAULT ALARMS AND VAD STOPPED ALARMS. DURING AN ATTEMPTED CONTROLLER EXCHANGE, THE PATIENT¿S BACKUP CONTROLLER EXHIBITED UNEXPECTED LOSSES OF POWER WHICH TRIGGERED VAD DISCONNECT ALARMS AND VAD STOPPED ALARMS. THE PATIENT DISCONNECTED THEIR BATTERIES WHICH TRIGGERED MULTIPLE POWER DISCONNECT ALARMS. UPON TRANSFER OF THE PATIENT TO THE EMERGENCY ROOM, THE BACKUP CONTROLLER WAS RECONNECTED TO THE VAD AND THERE WAS A SPIKE IN POWER WITH AN INABILITY TO GENERATE ROTATION AND FLOW, WHICH ALSO RECURRED WHEN THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE VAD WOULD NOT RESTART WHEN A THIRD CONTROLLER WAS ATTEMPTED FOR USE. THE PATIENT¿S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.7 AND THEIR HEART FAILURE WORSENED DUE TO BEING OFF THE VAD. THE PATIENT WAS ADMINISTERED AN INOTROPIC AGENT AND WAS TRANSFERRED TO HOSPICE. THE PRIMARY CONTROLLER, BACKUP CONTROLLER AND BATTERIES WERE REMOVED FROM SERVICE AS THE VAD REMAINS OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1027546 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707002639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death| H| R | DDMB1D4 ICD, 5076 LEAD, 6935M62 LEAD| SEE H10 |