HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-04395
- Event Type
- Malfunction
- Date Received
- September 13, 2018
- Date of Event
- August 23, 2018
- Report Date
- July 23, 2019
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000420
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INITIAL G4, H10 PRODUCT EVENT SUMMARY: ONE (1) CONTROLLER ((B)(6)) AND FIVE (5) BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(6), CONTAINED 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)(6), AS WELL AS A PREMATURE POWER SWITCHING EVENT DUE TO A COMMUNICATION ERROR INVOLVING (B)(6). IN ADDITION, DATA LOG FILES REVEALED MULTIPLE INSTANCES INVOLVING (B)(6) WHERE THE BATTERY¿S RELATIVE STATE OF CHARGE (RSOC) WAS BETWEEN 101-201, WHICH IS INDICATIVE OF A COMMUNICATION ERROR. AS A RESULT, THE REPORTED PREMATURE POWER SWITCHING EVENTS AND COMMUNICATION ERRORS WERE CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. ANALYSIS OF THE ALARM LOG FILES REVEALED THREE (3) CRITICAL BATTERY ALARMS INVOLVING (B)(6) DUE TO THE BATTERY DEPLETING BELOW 10% RSOC. AS A RESULT, THE REPORTED CRITICAL BATTERY ALARMS WERE CONFIRMED, ALTHOUGH THE ALARMS WERE NOT LOGGED WITH BATTERY CAPACITY ABOVE 25% RSOC AS REPORTED. LOG FILE ANALYSIS DID NOT REVEAL ANY EVIDENCE OF A LOSS OF POWER TO THE CONTROLLER OR PUMP STOP WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED "PUMP STOP" EVENT WAS NOT CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED RSOC VALUES BETWEEN 101-201 CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERY. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PR EMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS EVENT CAN BE ATTRIBUTED TO THE PATIENT ALLOWING THE BATTERY TO DEPLETE BELOW 10%. THERE IS AN INTERNAL INVESTIGATION FOR MOMENTARY DISCONNECTIONS. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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.
PRODUCT EVENT SUMMARY: THE CONTROLLER AND THE FIVE BATTERIES WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED 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 FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING THE FIVE BATTERIES, AS WELL AS A PREMATURE POWER SWITCHING EVENT DUE TO A COMMUNICATION ERROR INVOLVING (B)(4), THUS CONFIRMING THE REPORTED PREMATURE POWER SWITCHING EVENT. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILE REVEALED THREE CRITICAL BATTERY ALARMS INVOLVING (B)(4), LOGGED DUE TO THE BATTERY DEPLETING BELOW 10% RELATIVE STATE OF CHARGE (RSOC). AS A RESULT, THE REPORTED CRITICAL BATTERY ALARM EVENT WAS CONFIRMED, ALTHOUGH THE ALARMS WERE NOT LOGGED WITH BATTERY CAPACITY ABOVE 25% RSOC AS REPORTED. LOG FILE ANALYSIS DID NOT REVEAL ANY EVIDENCE OF A LOSS OF POWER TO THE CONTROLLER OR PUMP STOP WITHIN THE ANALYZED PERIOD; AS A RESULT, THE REPORTED "PUMP STOP" EVENT WAS NOT CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS EVENT CAN BE ATTRIBUTED TO THE PATIENT ALLOWING THE BATTERY TO DEPLETE BELOW 10%. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE MOMENTARY DISCONNECTIONS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. ADDITIONAL PRODUCTS: BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 4112, 4114 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 4112, 4114 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12, 4307 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 4112, 4114 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 4112, 4114 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 4112, 4114 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12, 19 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.
IT WAS FURTHER REPORTED AFTER LOG FILE REVIEW THAT ONE OF THE BATTERIES HAD A COMMUNICATION ERROR.
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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-12-31 UDI #: (B)(4) MFG DATE: 2017-12-07 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-12-31 UDI #: (B)(4) MFG DATE: 2017-12-18 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-12-31 UDI #: (B)(4) MFG DATE: 2017-12-16 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-12-31 UDI #: (B)(4) MFG DATE: 2017-12-07 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-12-31 UDI #: (B)(4) MFG DATE: 2017-12-07 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PREMATURE POWER SWITCHING ON MULTIPLE BATTERIES RESULTING IN A PUMP STOP. THE CONTROLLER AND ALL ASSOCIATED BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 716407 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1420-CONTROLLER | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | MCS VAD |