HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-03355
- Event Type
- Malfunction
- Date Received
- July 31, 2018
- Date of Event
- May 28, 2018
- Report Date
- April 28, 2021
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1336-2021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY: ONE CONTROLLER AND SIX BATTERIES WERE NOT RETURNED FOR EVALUATION. ANALYSIS OF THE LOG FILES REPORT REVEALED TWO CRITICAL BATTERY ALARMS WERE LOGGED ON (B)(6) 2018 AND (B)(6) 2018 INVOLVING (B)(6). REVIEW OF THE RAW LOG FILES COULD NOT BE CONDUCTED SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED "CRITICAL BATTERY ALARM" EVENT WAS CONFIRMED; HOWEVER, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED SINCE RAW LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. THE REPORTED "CONNECTION ISSUE" AND "POWER SWITCHING" EVENTS COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH CRITICAL BATTERY ALARMS, ARE MOST OFTEN ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES OR THE BATTERY DEPLETING BELOW 10%. A POSSIBLE ROOT CAUSE OF THE REPORTED "CONNECTION ISSUE" EVENT CAN BE ATTRIBUTED TO, BUT NOT LIMITED TO, CONNECTOR DAMAGE, BENT PINS AND/OR CONNECTOR WIRING FAILURE. A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERY. ADDITIONAL PRODUCTS: BATTERY / (B)(6). H3: NO. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 213 BATTERY / (B)(6). H3: NO. H6: JFDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 3221. H6: FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6). H3: NO. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 3221. H6: FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6). H3: NO. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 3221. H6: FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6). H3: NO. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 3221. H6: FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6). H3: NO. H6: FDA METHOD CODE(S): 4112, 4114. H6: FDA RESULTS CODE(S): 3221. H6: FDA CONCLUSION CODE(S): 67. 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.
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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE RECALL NUMBER. 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS FURTHER REPORTED THAT THE CONTROLLER WAS EXCHANGED AND SERVICING WAS PERFORMED ON THE BATTERIES.
IT WAS FURTHER REPORTED THAT THE PATIENT REPORTED POWER SWITCHING.
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: 2015-10-31 UDI #: (B)(4) MFG DATE: 2014-10-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4) MFG DATE: 2014-10-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4) MFG DATE: 2014-10-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4) MFG DATE: 2014-10-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4) MFG DATE: 2014-10-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4) MFG DATE: 2014-10-31 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT SIX BATTERIES HAD CRITICAL BATTERY ALARMS. IT WAS ALSO REPORTED THAT THE BATTERIES HAD CONNECTION ISSUES ON THE POWER PORTS OF THE CONTROLLER. THE BATTERIES REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576430 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | 1104 VAD. |