HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2020-01269
- Event Type
- Death
- Date Received
- February 5, 2020
- Date of Event
- January 19, 2020
- Report Date
- April 15, 2020
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. NEWLY RECEIVED INFORMATION INDICATED THAT THE PATIENT'S DEATH WAS SUSPECTED TO BE CLOSELY RELATED TO DRUG USE. 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 VENTRICULAR ASSIST DEVICE (VAD), CONTROLLER AND FOUR BATTERIES (B)(4) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE ALARM LOG FILES REVEALED THAT SEVERAL CRITICAL BATTERY ALARMS WERE RECORDED WITHIN THE ANALYZED PERIOD DUE TO THE BATTERY DEPLETING BELOW 10% RELATIVE STATE OF CHARGE (RSOC) INVOLVING (B)(4) AND (B)(4). ADDITIONALLY, MULTIPLE CONTROLLER FAULT ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2020 DUE TO THE BATTERY APPROACHING 0% RSOC. ANALYSIS OF THE ALARM LOG FILES DID NOT REVEAL ANY POWER DISCONNECT ALARMS. HOWEVER, REVIEW OF THE DATA LOG FILE REVEALED INSTANCES INVOLVING (B)(4) WHERE THE RSOC VALUES WERE LOGGED BETWEEN 101-201, WHICH IS INDICATIVE OF COMMUNICATION ERRORS. THE OBSERVED COMMUNICATION ERRORS ARE LIKELY RELATED TO THE REPORTED POWER DISCONNECT ALARMS. ANALYSIS OF THE EVENT LOG FILE REVEALED MULTIPLE CONTROLLER POWER UPS AND ASSOCIATED MOTOR STARTS LOGGED SINCE (B)(6) 2020, INDICATING LOSSES OF POWER TO THE CONTROLLER. NO ANOMALIES WERE RECORDED LEADING UP TO THE LOSSES OF POWER. IN ADDITION, LOG FILE ANALYSIS REVEALED A DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW ON (B)(6) 2020 TO PARAMETERS BELOW NORMAL OPERATING RANGE. MULTIPLE LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2020. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THERE IS NO EVIDENCE OF POWER SOURCES LUBRICATION PROCEDURE. BASED ON THE LOG FILE ANALYSIS, THE MOST LIKELY ROOT CAUSE OF THE POWER DISCONNECT ALARMS AND RSOC BETWEEN 101-201 CAN BE ATTRIBUTED TO COMMUNICATION ERRORS. POSSIBLE ROOT CAUSES OF THE COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERY, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY AND CONTROLLER FAULT ALARMS CAN BE ATTRIBUTED TO THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10% RSOC. A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES, AS DESCRIBED IN THE EVENT DETAILS, AND/OR TO THE PATIENT ALLOWING BATTERIES TO APPROACH 0% RSOC. 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. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE LOW FLOW EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE OBSERVED LOW FLOWS MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, INAPPROPRIATE VAD ROTATIONAL SPEED, AND/OR MOTOR NOT RUNNING. 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. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(4), H3: YES. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 3213. H6: FDA CONCLUSION CODE(S): 19, 4307. D4: SERIAL #: (B)(4), H3: YES. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 213. H6: FDA CONCLUSION CODE(S): 4310 D4: SERIAL #: (B)(4), H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 213. H6: FDA CONCLUSION CODE(S): 19. D4: SERIAL #: (B)(4), H3: YES. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 213. H6: FDA CONCLUSION CODE(S): 19. D4: SERIAL #: (B)(4), H3: YES. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 3213. H6: FDA CONCLUSION CODE(S): 4307. 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.
ADDITIONAL PRODUCTS: SERIAL #: (B)(6), DEVICE CODE(S): C62952, C63007, C63223. 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'S DEATH WAS SUSPECTED TO BE CLOSELY RELATED TO DRUG USE.
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. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0/ MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-MAR-2018 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-MAR-2017. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-SEP-2015 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 30-SEP-2014. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-2015 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-OCT-2014. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-NOV-2018 / SERIAL #: (B)(4)/ UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 19-NOV-2017. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-JUN-2019 / SERIAL #: (B)(4) / UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 11-JUN-2018. LABELED FOR SINGLE USE? NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT DIED FOLLOWING A VENTRICULAR ASSIST DEVICE STOP CAUSED BY DISCONNECTION OF BOTH POWER SOURCES. IT WAS ALSO REPORTED THAT THE CONTROLLER EXHIBITED CONTROLLER FAULT ALARMS AND POWER DISCONNECT ALARMS ASSOCIATED WITH THE BATTERIES, AND ONE BATTERY WAS ASSOCIATED WITH A CRITICAL BATTERY ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136836 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |