HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-00101
- Event Type
- Malfunction
- Date Received
- January 5, 2018
- Date of Event
- December 8, 2017
- Report Date
- October 29, 2018
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
UPDATED TO OTHER DEVICES INVOLVED: (B)(4) / MODEL #1650DE. (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
PRODUCT EVENT SUMMARY: THE CONTROLLER, (B)(4), AND FIVE (5) BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4), AS WELL AS POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4) WAS NOT INVOLVED IN ANY POWER SWITCHING EVENTS. ONE (1) CRITICAL BATTERY ALARM WAS LOGGED ON (B)(6), 2017 AT 12:04:23 DUE TO A COMMUNICATION ERROR INVOLVING (B)(4), AS MADE EVIDENT BY A RELATIVE STATE OF CHARGE (RSOC) VALUE GREATER THAN 100% ON THE LOG FILES, WHILE THE OTHER BATTERY CONNECTED TO THE CONTROLLER WAS DEPLETED TO LESS THAN 25% RSOC. AS A RESULT, THE REPORTED "POWER SWITCHING" AND "CRITICAL BATTERY ALARM" EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM EVENT CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THERE IS AN INTERNAL INVESTIGATION INVESTIGATING MOMENTARY DISCONNECTIONS. ADDITIONAL DEVICE(S) INVOLVED IN EVENT: D4: (B)(4) / MODEL #1650DE H6: METHOD CODE: 3372 D4: (B)(4) / MODEL #1650DE H6: METHOD CODE: 3372 D4: (B)(4) / MODEL #1650DE H6: METHOD CODE: 3372 D4: (B)(4) / MODEL #1650DE H6: METHOD CODE: 3372 D4: (B)(4) / MODEL #1650DE H6: METHOD CODE: 3372 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
PRODUCT ANALYSIS: IN RELATION TO THE REPORTED EVENT, THE CONTROLLER PASSED VISUAL INSPECTION AND PASSED FUNCTIONAL TESTING. HOWEVER THE REPORTED EVENT WAS CONFIRMED VIA LOG FILE REVIEW. ALL FIVE RETURNED BATTERIES PASSED EXTERNAL VISUAL INSPECTION, FUNCTIONAL CHECKS AND MACCOR TESTING. EXAMINATION OF CONTROLLER LOG FILES ALSO SHOW FOUR OUT OF THE FIVE BATTERIES WERE INVOLVED IN POWER SWITCHING EVENTS. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: (B)(4) / MODEL #1650DE D10: DEVICE AVAILABLE FOR EVALUATION: YES H6: METHOD CODE: 10, 23, 38 RESULTS CODE: 3213 CONCLUSION CODE: 25 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: (B)(4) / MODEL #1650DE D10: DEVICE AVAILABLE FOR EVALUATION: YES H6: METHOD CODE: 10, 23, 38 RESULTS CODE: 3213 CONCLUSION CODE: 25 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: (B)(4) / MODEL #1650DE D10: DEVICE AVAILABLE FOR EVALUATION: YES H6: METHOD CODE: 10, 23, 38 RESULTS CODE: 213 CONCLUSION CODE: 71 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: (B)(4) / MODEL #1650DE D10: DEVICE AVAILABLE FOR EVALUATION: YES H6: METHOD CODE: 10, 23, 38 RESULTS CODE: 3213 CONCLUSION CODE: 25 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: (B)(4) / MODEL #1650DE D10: DEVICE AVAILABLE FOR EVALUATION: YES H6: METHOD CODE: 10, 23, 38 RESULTS CODE: 3213 CONCLUSION CODE: 25 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
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. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, (B)(4)/ MODEL #1650DE / EXP. DATE: 2017-05-31, DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATION ANTICIPATED, MFG. DATE: 2016-05-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, (B)(4) / MODEL #1650DE / EXP. DATE: 2017-05-31, DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATION ANTICIPATED, MFG. DATE: 2016-05-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, (B)(4) / MODEL #1650DE / EXP. DATE: 2017-05-31, DEVICE AVAILABLE FOR EVALUATION: YES, DEVICE EVALUATION ANTICIPATED, MFG. DATE: 2016-05-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, (B)(4) / MODEL #1650DE / EXP. DATE: 2017-05-31, DEVICE AVAILABLE FOR EVALUATION: YES, DEVICE EVALUATION ANTICIPATED, MFG. DATE: 2016-05-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, (B)(4) / MODEL #1650DE / EXP. DATE: 2017-07-31, DEVICE AVAILABLE FOR EVALUATION: YES, DEVICE EVALUATION ANTICIPATED, MFG. DATE: 2016-07-31. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT COMPLAINED ABOUT EXPERIENCING POWER SWITCHING EVENTS ON FIVE BATTERIES. THE PATIENT PRESENTED TO THE SITE AND EXPERIENCED A CRITICAL BATTERY ALARM. ALL DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13094 | HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420-MCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MCS UNKNOWN VAD |