HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-08479
- Event Type
- Death
- Date Received
- December 14, 2022
- Date of Event
- December 5, 2022
- Report Date
- May 15, 2023
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-OCT-2020 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 01-OCT-2019. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER. MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-OCT-2020 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 01-OCT-2019 LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER ALTERNATING CURRENT (CAC) ADAPTER. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. LABELED FOR SINGLE USE: NO. (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE ADDITIONAL EVENT DETAILS OF THE EVENT, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, 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 IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. PRODUCT EVENT SUMMARY: VENTRICULAR ASSIST DEVICE (B)(6) , TWO (2) CONTROLLERS (B)(6) AND ONE (1) CONTROLLER AC ADAPTER (B)(6) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED (B)(6) WAS THE PRIMARY CONTROLLER, INITIALLY IN USE DURING THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED A TRANSIENT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS ON (B)(6) 2022 AND NINE (9) LOW FLOW ALARMS HAVE BEEN LOGGED ON (B)(6) 2022. REVIEW OF THE EVENT LOG FILE ASSOCIATED WITH (B)(6) THEN REVEALED A CONTROLLER POWER UP EVENT LOGGED ON (B)(6) 2022 AT 16:30:37. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED A POWER ADAPTER WAS CONNECTED TO POWER PORT ONE AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 96% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR EIGHT (8) SECONDS. REVIEW OF THE ALARM LOG FILE ASSOCIATED WITH (B)(6) REVEALED FIVE (5) VAD STOPPED ALARMS AND NINE (9) VAD DISCONNECT ALARMS WERE THEN LOGGED ON (B)(6) 2022. THE FIRST VAD STOPPED ALARM WAS LOGGED AT 16:31:05, INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS. THIS VAD STOPPED ALARM WAS FOLLOWED BY MULTIPLE CONTROLLER POWER UP EVENTS, ADDITIONAL VAD STOPPED ALARMS INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS, AND VAD DISCONNECT ALARMS INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING AND THE REPORTED CONTROLLER EXCHANGE. REVIEW OF THE LOG FILES ASSOCIATED WITH (B)(6) REVEALED A CONTROLLER POWER UP EVENT LOGGED ON (B)(6) 2022 AT 16:44:25, INDICATING THAT THE CONTROLLER WAS PUT INTO USE FOLLOWING THE REPORTED CONTROLLER EXCHANGE. REVIEW OF THE ALARM LOG FILE ASSOCIATED WITH (B)(6) REVEALED SIXTEEN (16) VAD DISCONNECT ALARMS AND FOURTEEN (14) VAD STOPPED ALARMS WERE THEN LOGGED ON (B)(6) 2022. THE FIRST VAD DISCONNECT ALARM WAS LOGGED AT 16:44:34, LIKELY DUE TO THE CONTROLLER BEING POWERED UP WITH A DRIVELINE CONNECTED PRIOR TO THE REPORTED CONTROLLER EXCHANGE. THE VAD STOPPED ALARM WAS THEN LOGGED AT 16:46:23, INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS. THIS VAD STOPPED ALARM WAS FOLLOWED BY MULTIPLE CONTROLLER POWER UP EVENTS, ADDITIONAL VAD STOPPED ALARMS INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS, AND ADDITIONAL VAD DISCONNECT ALARMS INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE LOW FLOW EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR POOR VAD FILLING. A POSSIBLE ROOT CAUSE OF THE INITIAL LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. THE MOST LIKELY ROOT CAUSE OF THE REMAINING CONTROLLER POWER UP EVENTS INVOLVING THE CONTROLLERS CAN BE ATTRIBUTED TO A CONTROLLER EXCHANGE AND TROUBLESHOOTING OF THE VAD STOPPED ALARMS. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO PHYSICAL DISCONNECTIONS OF THE DRIVELINE FROM THE CONTROLLER DURING TROUBLESHOOTING OF THE VAD STOPPED ALARMS AND A CONTROLLER BEING POWERED UP WITHOUT THE DRIVELINE CONNECTED DURING THE REPORTED CONTROLLER EXCHANGE. THE MOST LIKELY ROOT CAUSE OF THE VAD STOPPED ALARMS CAN BE ATTRIBUTED TO FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. (B)(6) WAS NOT IN SCOPE OF FCA CVG-21-Q3-21. CAPA PR00532915 IS INVESTIGATING PUMP FAILURES TO RESTART OUTSIDE THE SUBPOPULATION OF FCA CVG-21-Q3-21. 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 IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. UPDATED SECTIONS: - A2 AGE AT EVENT - A3. SEX - A4. WEIGHT IN LBS - B2. OUTCOME ATTRIBUTED TO ADVERSE EVENT - B2 DATE OF DEATH - B5.DESC EVT PROBLEM - H1. TYPE OF REPORTABLE EVENT - H2. IF FOLLOW-UP, WHAT TYPE? - H6 PATIENT CODES (IME/ANNEX E) - H6 IMF (ANNEX F) HEALTH IMPACT - H10. ADDT MANUFACTURER FOR MDR (CODES FOR ASSOCIATED CODES) CORRECTED SECTIONS: - B3. DATE OF EVENT ADDITIONAL PRODUCTS: (B)(6) ¿ CONTROLLER 2.0 H6: PATIENT IME CODE(S): E2402 H6: IMF CODE(S): F0801, F21, F02 (B)(6) ¿ CONTROLLER 2.0 H6: PATIENT IME CODE(S): E2402 H6: IMF CODE(S): F0801, F21, F02 (B)(6) ¿ CAC ADAPTER H6: PATIENT IME CODE(S): E2402 H6: IMF CODE(S): F0801, F21, F02 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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 IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. UPDATED SECTIONS: - H10 ADDT MANUFACTURER FOR MDR: UPDATED TO INCLUDE THE SERIAL NUMBER OF THE CAC ADAPTER ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER ALTERNATING CURRENT (CAC) ADAPTER SERIAL#: (B)(6) INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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: THE PUMP(B)(6) TWO (2) CONTROLLERS (B)(6) AND ONE (1) CONTROLLER AC ADAPTER (CAC218879) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED (B)(6) WAS THE PRIMARY CONTROLLER, INITIALLY IN USE DURING THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED A TRANSIENT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS ON 05/DEC/2022 AND NINE (9) LOW FLOW ALARMS HAVE BEEN LOGGED ON 05/DEC/2022. REVIEW OF THE EVENT LOG FILE ASSOCIATED WITH (B)(6) THEN REVEALED A CONTROLLER POWER UP EVENT LOGGED ON 12/DEC/2022 AT 16:30:37. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED A POWER ADAPTER WAS CONNECTED TO POWER PORT ONE AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 96% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR EIGHT (8) SECONDS. REVIEW OF THE ALARM LOG FILE ASSOCIATED WITH (B)(6) REVEALED FIVE (5) VAD STOPPED ALARMS AND NINE (9) VAD DISCONNECT ALARMS WERE THEN LOGGED ON 12/DEC/2022. THE FIRST VAD STOPPED ALARM WAS LOGGED AT 16:31:05, INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS. THIS VAD STOPPED ALARM WAS FOLLOWED BY MULTIPLE CONTROLLER POWER UP EVENTS, ADDITIONAL VAD STOPPED ALARMS INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS, AND VAD DISCONNECT ALARMS INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING AND THE REPORTED CONTROLLER EXCHANGE. REVIEW OF THE LOG FILES ASSOCIATED WITH (B)(6) REVEALED A CONTROLLER POWER UP EVENT LOGGED ON 12/DEC/2022 AT 16:44:25, INDICATING THAT THE CONTROLLER WAS PUT INTO USE FOLLOWING THE REPORTED CONTROLLER EXCHANGE. REVIEW OF THE ALARM LOG FILE ASSOCIATED WITH (B)(6) SIXTEEN (16) VAD DISCONNECT ALARMS AND FOURTEEN (14) VAD STOPPED ALARMS WERE THEN LOGGED ON 12/DEC/2022. THE FIRST VAD DISCONNECT ALARM WAS LOGGED AT 16:44:34, LIKELY DUE TO THE CONTROLLER BEING POWERED UP WITH A DRIVELINE CONNECTED PRIOR TO THE REPORTED CONTROLLER EXCHANGE. THE VAD STOPPED ALARM WAS THEN LOGGED AT 16:46:23, INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS. THIS VAD STOPPED ALARM WAS FOLLOWED BY MULTIPLE CONTROLLER POWER UP EVENTS, ADDITIONAL VAD STOPPED ALARMS INDICATING THAT THE PUMP FAILED TO START AFTER MULTIPLE ATTEMPTS, AND ADDITIONAL VAD DISCONNECT ALARMS INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE LOW FLOW EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR POOR VAD FILLING. A POSSIBLE ROOT CAUSE OF THE INITIAL LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. THE MOST LIKELY ROOT CAUSE OF THE REMAINING CONTROLLER POWER UP EVENTS INVOLVING THE CONTROLLERS CAN BE ATTRIBUTED TO A CONTROLLER EXCHANGE AND TROUBLESHOOTING OF THE VAD STOPPED ALARMS. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO PHYSICAL DISCONNECTIONS OF THE DRIVELINE FROM THE CONTROLLER DURING TROUBLESHOOTING OF THE VAD STOPPED ALARMS AND A CONTROLLER BEING POWERED UP WITHOUT THE DRIVELINE CONNECTED DURING THE REPORTED CONTROLLER EXCHANGE. THE MOST LIKELY ROOT CAUSE OF THE VAD STOPPED ALARMS CAN BE ATTRIBUTED TO FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. (B)(6) WAS NOT IN SCOPE OF FCA CVG-21-Q3-21. CAPA PR00532915 IS INVESTIGATING PUMP FAILURES TO RESTART OUTSIDE THE SUBPOPULATION OF FCA CVG-21-Q3-21. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D10 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: SERIAL #: (B)(6) H3: YES H4: MFG DATE: 10-OCT-2019 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D10, D15 D4: SERIAL #: CAC218879 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 REPORTED THAT VENTRICULAR ASSIST DEVICE EXHIBITED LOW FLOW ALARMS AND THAT THE PATIENT REPORTED A VAD STOPPED ALARM WAS SEEN ON THE CONTROLLER. THE PATIENT DID A CONTROLLER EXCHANGE AND CONTINUED TO GET THE VAD STOPPED ALARM. THE PATIENT WENT TO THE SITE URGENTLY VIA AMBULANCE, BUT THE VAD STOPPED ALARM CONTINUED. THE VAD WOULD NOT RESTART. THE PATIENT MENTIONED THAT THE CONTROLLER HAD EXPERIENCED POWER OUTAGES FOR TWO TO THREE DAYS WHILE CONNECTED TO THE ALTERNATING CURRENT (AC) ADAPTER. THE PATIENT IS HEMODYNAMICALLY STABLE IN THE INTENSIVE CARE UNIT (ICU). ONE CONTROLLER WAS EXCHANGED. THE CONTROLLER, AC ADAPTER, AND VAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT WITHIN A FEW DAYS OF BEING IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT¿S GENERAL CONDITION DETERIORATED AND THE PATIENT SUBSEQUENTLY EXPIRED. THE CAUSE OF DEATH WAS STATED TO BE ¿GENERAL CONDITION DISORDER¿.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446691 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Hospitalization| D |