HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2023-03522
- Event Type
- Death
- Date Received
- September 13, 2023
- Date of Event
- September 7, 2023
- Report Date
- June 19, 2024
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: MODEL #: 1420-CONTROLLER / CATALOG #: 1420-CONTROLLER / EXPIRATION DATE: 28-FEB-2021 / SERIAL OR LOT#: (B)(6), UDI #: (B)(4), D9: NO, H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H4: MFG DATE: 28-FEB-2020 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: MODEL #: 1420-CONTROLLER / CATALOG #: 1420-CONTROLLER / EXPIRATION DATE: 31-OCT-2020 / SERIAL OR LOT#: (B)(6), UDI #: (B)(4), D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: 08-OCT-2019 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, UDI #: (B)(4). D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H4: MFG DATE: H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, UDI #: (B)(4). D9: NO. H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H4: MFG DATE: H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. D9: NO. H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H5: NO. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. D9: NO. H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H5: NO. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. 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 AS ADDITIONAL INFORMATION HAS BEING RECEIVED FOR THIS EVENT. 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 ADDITIONAL INFORMATION RECEIVED. UPDATED H10. D4: MODEL/CATALOG #:1650, EXPIRATION DATE: 31-JUL-2023/ SERIAL OR LOT#: (B)(6), UDI #: (B)(4), H4: MFG DATE: 27-JUL-2022; D4: MODEL #: 1650, CATALOG #:1650, EXPIRATION DATE: 31-JUL-2023/SERIAL OR LOT#: ; (B)(6) UDI #: (B)(4) H4: MFG DATE: 27-JUL-2022; D4: MODEL #: 1650 / CATALOG #:1650 / EXPIRATION DATE: 31-JUL-2023 / SERIAL OR LOT#: (B)(6) UDI #: (B)(4) H4: MFG DATE: 27-JUL-2022; D4: MODEL #: 1650 / CATALOG #:1650 / EXPIRATION DATE: 31-AUG 2023/ SERIAL OR LOT#: (B)(6) UDI #: (B)(4) H4: MFG DATE: 03-AUG-2022. 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 ADDITIONAL INFORMATION. ADDITIONAL PRODUCTS: D1: CONTROLLER D4: (B)(6) H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. 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. 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)) AND ONE (1) CONTROLLER ((B)(6)) WERE NOT RETURNED FOR EVALUATION. TWO (2) CONTROLLERS ((B)(6)) AND FOUR (4) BATTERIES ((B)(6)) WERE RETURNED FOR EVALUATION. NO PERFORMANCE ALLEGATIONS WERE MADE AGAINST (B)(6). REVIEW OF (B)(6) MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOC IATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLERS AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INTERNAL INSPECTION OF THE DEVICES DID NOT REVEAL ANY ANOMALIES. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PATIENT¿S PRIMARY CONTROLLER, INITIALLY IN USE AT THE TIME OF THE REPORTED EVENT. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED THREE (3) CONTROLLER POWER-UP EVENTS WITH AN ASSOCIATED PUMP START LOGGED ON (B)(6) 2023 AT 12:49:27, AT 12:49:01, AND AT 23:14:45, INDICATING LOSSES OF POWER TO THE CONTROLLER. NO ANOMALIES WERE RECORDED LEADING UP TO THE LOSSES OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR 17 SECONDS, 30 SECONDS, AND 21 SECONDS, RESPECTIVELY. THIS WAS FOLLOWED BY FOUR (4) CRITICAL BATTERY ALARMS INVOLVING (B)(6) ON (B)(6) 2023 DUE TO THE PATIENT ALLOWING THE BATTERY TO DEPLETE BELOW 10% AND THIRTEEN (13) CONTROLLER FAULT ALARMS WERE LOGGED ON (B)(6) 2023 DUE TO EITHER A POWER OUT OF RANGE OR A FAULT IN THE CONTROLLER¿S ACTIVE POWER SELECTION (APS) CIRCUIT. THE CONTROLLER FAULT ALARMS DUE TO A POWER OUT OF RANGE WERE DUE TO (B)(6) APPROACHING 0% RELATIVE STATE OF CHARGE (RSOC). THE LOG FILES RECORDED THE PUMP'S POWER CONSUMPTION WAS SIGNIFICANTLY BELOW NORMAL OPERATING RANGE, INDICATING THERE WAS NOT ENOUGH CURRENT BEING DRAWN FROM THE BATTERY. THE CONTROLLER FAULT ALARMS DUE TO A FAULT IN THE CONTROLLER¿S APS CIRCUIT WERE LIKELY TRIGGERED DUE TO THE DEPLETED BATTERY BEING CONNECTED TO THE CONTROLLER WITH A VERY LOW RSOC AND A LOW OUTPUT VOLTAGE, RESULTING IN A CURRENT BELOW THE EXPECTED RANGE IN THE APS CIRCUIT. THE APS CIRCUIT MANAGES THE SELECTION OF THE ACTIVE POWER SOURCE. WHEN THE MAIN INTEGRATED CHIP SENSES THAT THE CURRENT FROM THE APS CIRCUIT IS OUTSIDE THE NORMAL OR EXPECTED RANGE, A CONTROLLER FAULT ALARM IS TRIGGERED. THE BATTERY LIKELY RECOVERED ENOUGH CHARGE TO START THE CONTROLLER AGAIN, BUT QUICKLY DEPLETED, CAUSING ADDITIONAL CONTROLLER POWER UP EVENTS. FOLLOWING THE CONTROLLER FAULT ALARMS, LOG FILES REVEALED INSTANCES THAT ONLY ONE (1) POWER SOURCE WAS CONNECTED TO THE CONTROLLER DURING THE ATTEMPTED PUMP START EVENTS. ANALYSIS OF THE DATA LOG FILE REVEALED THAT DURING THE ATTEMPTED PUMP START EVENTS, SAFETY ALERT WORD (SAW) VALUES WERE RECORDED ON (B)(6) , INDICATING AN OVERCURRENT ALERT. DURING THE ATTEMPTED PUMP START EVENTS, LOG FILES RECORDED HIGH POWER CONSUMPTION, WHICH REQUIRED MORE CURRENT FROM THE BATTERY. IT IS LIKELY THAT THE OVERCURRENT CONDITION PREVENTED THE BATTERY FROM PROVIDING POWER, RESULTING IN ADDITIONAL LOSSES OF POWER TO THE CONTROLLER. THIS WAS THEN FOLLOWED BY FOUR (4) VAD STOPPED ALARMS LOGGED STARTING AT 09:40:13 DUE TO A FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. IN ADDITION, LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED MOTOR START EVENTS RECORDED ON 08/FEB/2021 AT 10:48:59, ON 17/MAR/2021 AT 10:38:14, ON 16/NOV/2021 AT 11:52:53, ON 24/NOV/2021 AT 17:47:17, ON 13/SEP/2022 AT 00:50:55, ON 13/SEP/2022 AT 11:07:44, ON 27/FEB/2023 AT 18:43:50, ON 10/APR/2023 AT 12:32:22, ON 07/SEP/2023 AT 12:48:31, ON 07/SEP/2023 AT 12:49:09, ON 07/SEP/2023 AT 23:14:49 IN WHICH THE MOTOR START PARAMETER WAS ATYPICAL. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) ALSO REVEALED SEVERAL INTERMITTENT INCREASES IN POWER CONSUMPTION LEADING TO PARAMETERS ABOVE NORMAL OPER ATING RANGE WITHIN THE ANALYZED PERIOD. REVIEW OF THE EVENT LOG FILE REVEALED A CORRUPTED DATA ENTRY WAS LOGGED WITH THE DATE OF 31/FEB/2099 AND TIME OF 00:00:00 HOURS. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. FURTHER INVESTIGATION USING A REPRESENTATIVE SAMPLE REVEALED THAT THE REPORTED EVENT CAN BE REPLICATED WHEN THE CONTROLLER IS EXPOSED TO VOLTAGE SPIKES OR NOISE CAUSED WHEN CONNECTING A BATTERY TO THE CONTROLLER, RESULTING IN A TEMPORARY¿LOSS OF COMMUNICATION BETWEEN THE REAL TIME CLOCK CIRCUIT AND THE USER INTERFACE CIRCUIT (UIC). THE UIC IS RESPONSIBLE FOR OPERATION OF THE CONTROLLER, INCLUDING RECORDING DATA IN THE CONTROLLER LOG FILES. THEREFORE, THE LOSS OF COMMUNICATION CAUSED THE CONTROLLER TO RECORD AN INVALID DATE AND TIME IN THE DATA LOG FILE. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REAL TIME CLOCK EVENT CAN BE ATTRIBUTED TO AN INCORRECT TIME STAMP IN THE DATA LOG FILE DUE TO A VOLTAGE SPIKE OR NOISE CAUSED WHEN CONNECTING A BATTERY TO THE CONTROLLER. REVIEW OF THE EVENT LOG FILE ASSOCIATED WITH (B)(6) REVEALED A CONTROLLER POWER UP EVENT WAS LOGGED, INDICATING THE CONTROLLER WAS PUT IN USE FOLLOWING A CONTROLLER EXCHANGE. OF NOTE, THE PUMP ID WAS NOT SET DURING THE INITIAL PROGRAMMING OF THE CONTROLLER. ADDITIONALLY, MULTIPLE CLOCK CHANGE EVENTS WERE LOGGED WITHIN THE ANALYZED PERIOD. IF THE PUMP ID IS NOT SET WHEN THE CONTROLLER IS CONNECTED TO THE MONITOR, THE MONITOR WILL AUTOMATICALLY SET THE CONTROLLER DATE/TIME TO MATCH THE CURRENT DATE/TIME OF THE MONITOR. THE OBSERVED PUMP ID NOT SET IN THE LOG FILES AND CLOCK CHANGE EVENTS ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED PUMP ID NOT SET IN THE LOG FILES COULD BE ATTRIBUTED TO AN INCORRECT SET UP PROCESS. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CLOCK CHANGE EVENTS CAN BE ATTRIBUTED TO THE CONTROLLER WITH NO SET PUMP ID CONNECTED TO THE MONITOR, TRIGGERING THE MONITOR TO UPDATE THE DATE/TIME OF THE CONTROLLER. AFTER THE INITIAL CONTROLLER POWER UP, THE DATE/TIME WAS UPDATED BY THE MONITOR TO (B)(6) 2006 ON THE CONTROLLER. DUE TO THE ADJUSTMENT IN DATE/TIME ON THE CONTROLLER, THE SEQUENCE OF EVENTS IN VOLVING (B)(6) COULD NOT BE DETERMINED. REVIEW OF THE EVENT LOG FILE ASSOCIATED WITH (B)(6) ALSO REVEALED TWO (2) ADDITIONAL CONTROLLER POWER UP EVENTS WERE THEN LOGGED LIKELY DUE TO TROUBLESHOOTING. REVIEW OF THE ALARM LOG FILE ASSOCIATED WITH (B)(6) THEN REVEALED THREE (3) LOW FLOW ALARMS WERE LOGGED. (B)(6) WAS LOADED WITH A SOFTWARE CONTAINING AN UNAPPROVED PUMP START ALGORITHM. THE CONTROLLER LOG FILES ASSOCIATED WITH (B)(6) WAS NOT PERFORMED SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED CONTROLLER FAULT ALARMS AND VAD STOPPED ALARMS INVOLVING (B)(6), AND THE REPORTED "BATTERY EMPTY ALARM" WERE CONFIRMED. THE REPORTED VAD STOPPED ALARMS INVOLVING (B)(6) WAS NOT CONFIRMED. BASED ON THE RISK DOCUMENTATION, POSSIBLE ROOT CAUSES OF THE OBSERVED HIGH POWER EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS, INCLUDING BUT NOT LIMITED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION, INAPPROPRIATE PUMP ROTATIONAL SPEED, AND/OR PATIENT RELATED FACTORS. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE OBSERVED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO POOR VAD FILLING, THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. BASED ON A HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF ATYPICAL MOTOR START PARAMETER(S) MAY BE ATTRIBUTED, BUT NOT LIMITED, TO OUTER SHROUD CONTACT THAT CREATES MORE FRICTION AT THE HOUSING TO IMPELLER INTERFACE DURING PUMP STARTUP. A POSSIBLE ROOT CAUSE OF THE CRITICAL BATTERY ALARMS EVENT AND THE CONTROLLER FAULT ALARMS EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO THE PATIENT ALLOWING THE BATTERY TO DEPLETE BELOW 10% RSOC. POSSIBLE ROOT CAUSES OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES, TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES, TO THE PATIENT ALLOWING THE BATTERY TO DEP LETE BELOW 10% RSOC, AND/OR TO TROUBLESHOOTING OF THE CONTROLLER DURING A CONTROLLER EXCHANGE. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. CAPA PR00544941 IS INVESTIGATING CONTROLLER LOSSES OF POWER DURING PUMP START DUE TO BATTERY DISCHARGE OVERCURRENT CONDITION. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED FAILURE TO RESTART EVENT INVOLVING (B)(6) CAN BE ATTRIBUTED, BUT NOT LIMITED TO THE FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. AN INTERNAL INVESTIGATION WAS CREATED TO FURTHER INVESTIGATE FAILURES OF THE PUMP TO RESTART. THE MOST LIKELY ROOT CAUSE OF THE REPORTED VAD STOPPED ALARMS CAN BE ATTRIBUTED TO A FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. (B)(6) WAS IN SCOPE OF FCA CVG-21-Q3-21. CAPA PR00532915 IS INVESTIGATING PUMP FAILURES TO RESTART. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00532915, THE MOST LIKELY ROOT CAUSE OF THE FAILURE TO RESTART EVENT MAY BE ATTRIBUTED TO OUTER SHROUD CONTACT THAT CREATED MORE FRICTION AT THE HOUSING TO IMPELLER INTERFACE. ADDITIONAL PRODUCTS: (B)(6) H3: YES (B)(6) H3: YES (B)(6) H3: YES (B)(6) H3: YES (B)(6) H3: YES (B)(6) H3: YES 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT DURING A BATTERY EXCHANGE THERE WERE TWO VENTRICULAR ASSIST DEVICE (VAD) STOPS, THEN THE VAD STARTED AGAIN. IT WAS NOTED THAT BOTH BATTERIES WERE BELOW 25% WITH A "BATTERY EMPTY ALARM", THE BATTERY ON PORT 2 WAS DISCONNECTED AND ONLY ONE BATTERY REMAINED ON THE SYSTEM WHICH WAS COMPLETELY DRAINED CAUSING ANOTHER VAD STOP WHICH CAUSED A CONTROLLER FAULT ALARM. THE BATTERIES WERE EXCHANGED BY THE PHYSICIAN AND THE VAD DID NOT RESTART. THERE WAS AN ATTEMPT TO RESTART THE VAD WITH A SECOND CONTROLLER, HOWEVER IT WAS NOT SUCCESSFUL. A THIRD CONTROLLER WITH A MODIFIED SOFTWARE WAS USED AND THE VAD FINALLY RESTARTED WITH SUFFICIENT PUMP FLOWS. IT WAS NOTED THAT THE PUMP STOPPED FOR ALMOST TWELVE (12) HOURS. THE PATIENT WAS INTUBATED HOWEVER DID NOT VENTILATE WHILE CONSCIOUS, THE PATIENT EXPERIENCED BRAIN HYPOXIA AND NEEDED TO BE RESUSCITATED. SUBSEQUENTLY THE PATIENT DIED.
IT WAS FURTHER REPORTED THAT LOG FILES REVIEW REVEALED THE CONTROLLER ALSO EXHIBITED AN UNEXPECTED LOSS OF POWER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1615012 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death |