HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-00370
- Event Type
- Death
- Date Received
- January 28, 2022
- Date of Event
- January 12, 2022
- Report Date
- April 15, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707005364
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420, CATALOG #: 1420, EXPIRATION DATE: 31-DEC-2021, SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 27-JAN-2022. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEV RTN TO MFR? YES. MFG DATE: 01-DEC-2020. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-JAN-2022, 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: 15-JAN-2021. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-DEC-2021, 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-DEC-2020. LABELED FOR SINGLE USE: NO. (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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 PUMP (B)(6) AND TWO BATTERIES (B)(6) WERE NOT RETURNED FOR EVALUATION. ONE (1) CONTROLLER (B)(6) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT WAS FOUND DEAD AT HOME; THE CAUSE OF DEATH WAS UNKNOWN. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED A SUDDEN, SUSTAINED DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON 12/JAN/2022 LEADING TO PARAMETERS BELOW NORMAL OPERATING RANGE. FIVE (5) LOW FLOW ALARMS WERE LOGGED STARTING ON 12/JAN/2022 AT 16:53:34. REVIEW OF THE ALARM LOG FILE ALSO REVEALED 33 CRITICAL BATTERY ALARMS LOGGED STARTING ON 12/JAN/2022 AT 22:24:51 AND 13 CONTROLLER FAULT ALARMS LOGGED ON 13/JAN/2022 STARTING AT 00:46:49. THE CRITICAL BATTERY ALARMS WERE THE RESULT OF THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10% RELATIVE STATE OF CHARGE (RSOC). ANALYSIS OF THE LOG FILES REVEALED THAT, AT THE TIME OF THE FIRST CRITICAL BATTERY ALARM, (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 9% RELATIVE STATE OF CHARGE (RSOC) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 24% RSOC. BOTH BATTERIES WERE THEN ALLOWED TO CONTINUE DEPLETING. A CONTROLLER FAULT ALARM WILL OCCUR IF THE BATTERY IS APPROACHING 0% RSOC. LOG FILE ANALYSIS REVEALED A CONTROLLER POWER-UP EVENT ON 13/JAN/2022 AT 08:06:53. THE DATA POINT RECORDED BEFORE THE POWER UP EVENT REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2); BOTH BATTERIES HAD BEEN ALLOWED TO DEPLETE COMPLETELY, RESULTING IN A LOSS OF POWER TO THE CONTROLLER. THE CONTROLLER HAD BEEN WITHOUT POWER FOR 6 HOURS, 15 MINUTES, AND 10 SECONDS. SEVERAL ADDITIONAL CONTROLLER POWER-UP EVENTS WERE THEN LOGGED BETWEEN 13/JAN/2022 AT 12:03:40 AND 14/JAN/2022 AT 11:48:17, LIKELY DURING TROUBLESHOOTING AFTER THE PATIENT WAS FOUND. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE LIMITED INFORMATION AVAILABLE, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH 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. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS, CONTROLLER FAULT ALARMS, AND CONTROLLER LOSS OF POWER CAN BE ATTRIBUTED TO THE PATIENT ALLOWING THE BATTERIES TO DEPLETE. (B)(4) WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. PER THE INSTRUCTIONS FOR USE, DEATH IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: SERIAL#: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15, B01 H6: FDA RESULTS CODE(S): C23 H6: FDA CONCLUSION CODE(S): D11 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL#: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C23 H6: FDA CONCLUSION CODE(S): D11 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL#: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C23 H6: FDA CONCLUSION CODE(S): D11 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 THE PATIENT WAS FOUND DEAD AT HOME. THE CAUSE OF DEATH IS UNKNOWN. A LOGFILE REVIEW DEMONSTRATED THAT THERE WERE NUMEROUS CRITICAL BATTERY ALARMS ON TWO BATTERIES, SEVERAL CONTROLLER FAULT ALARMS AND UNEXPECTED LOSS OF POWER ON THE CONTROLLER. BELOW NORMAL POWER CONSUMPTION AND SEVERAL LOW FLOW ALARMS WERE ALSO LOGGED ON THE VENTRICULAR ASSIST DEVICE (VAD).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 892492 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | MCS1705PU | 00888707005364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Death |