HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0

Report

Report Number: 3007042319-2017-03810
Event Type: Malfunction
Date Received: October 24, 2017
Date of Event: September 21, 2017
Report Date: August 23, 2019
Manufacturer: HEARTWARE, INC
Product Code: DSQ
PMA / PMN Number: P100047
Removal / Correction Number: Z-1903-2018
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

PRODUCT EVENT SUMMARY: ONE (1) CONTROLLER, SIX (6) BATTERIES (B)(6) AND TWO (2) CONTROLLER AC ADAPTERS ((B)(6)) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE UNITS PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER SOFTWARE CONTAINS 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 PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6). DATA LOG FILE ALSO REVEALED A PREMATURE POWER SWITCHING EVENT THAT WAS DUE TO COMMUNICATION ERRORS INVOLVING (B)(6). ADDITIONALLY, DATA LOG FILES REVEALED A RELATIVE STATE OF CHARGE (RSOC) BETWEEN 101-201 INVOLVING (B)(6), WHICH IS INDICATIVE OF A COMMUNICATION ERROR. THERE IS NO EVIDENCE OF POWER SOURCE LUBRICATION PROCEDURE PERFORMED ON (B)(6). AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON (B)(6) ON (B)(6) 2019. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. A POSSIBLE ROOT CAUSES OF THE REPORTED COMMUNICATION ERROR 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. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / SERIAL #: (B)(6) D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 12 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / SERIAL #: (B)(6) D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 12 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / SERIAL #: (B)(6). D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 12 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / SERIAL #: (B)(6). D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 12, 4307 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / SERIAL #: (B)(6) D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / SERIAL #: (B)(6) D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 12 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER D4: MODEL #: 1430DE / SERIAL #: (B)(6). D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 67 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER D4: MODEL #: 1430DE / SERIAL #: (B)(6). D10: YES, RETURN DATE: 20-OCT-2017 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 67 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 0

THIS REPORT WAS IDENTIFIED FOLLOWING THE CONVERSION OF COMPLAINT FILES FROM THE LEGACY COMPLAINT HANDLING SYSTEM FOLLOWING INTEGRATION AND IS BEING SUBMITTED TO REPORT INVESTIGATION RESULTS. PRODUCT EVENT SUMMARY IT WAS REPORTED FROM THE SITE THAT POWER SWITCHING WAS OCCURRING. ONE (1) CONTROLLER (CON303130), SIX (6) BATTERIES (BAT201704, BAT205166, BAT205259, BAT209318, BAT214739 AND BAT214765) AND TWO (2) CONTROLLER AC ADAPTERS (CAC200139 AND CAC200234) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE UNITS PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER SOFTWARE CONTAINS 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 PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT201704, BAT205166, BAT205259, BAT209318, BAT214739 AND BAT214765. DATA LOG FILE ALSO REVEALED A PREMATURE POWER SWITCHING EVENT THAT WAS DUE TO COMMUNICATION ERRORS INVOLVING BAT214765. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. BAT209318 - BATTERY. CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES. RETURNED 2017-11-17, DEVICE MANUFACTURE DATE: 2015-09-30. (B)(4). BAT201704 - BATTERY, CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES, RETURNED 2017-11-16, DEVICE MANUFACTURE DATE: 2014-10-31. (B)(4), BAT205259 - BATTERY, CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES, RETURNED 2017-11-17, DEVICE MANUFACTURE DATE: 2015-02-28, (B)(4), BAT205166 - BATTERY,CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES, RETURNED 2017-11-16, DEVICE MANUFACTURE DATE: 2015-02-28, (B)(4), BAT214765 - BATTERY, CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES, RETURNED 2017-11-16, DEVICE MANUFACTURE DATE: 2016-02-28, (B)(4), BAT214739 - BATTERY, CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES, RETURNED 2017-11-16, DEVICE MANUFACTURE DATE: 2016-02-28, (B)(4), CAC200139 - CONTROLLER AC ADAPTER, CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES, RETURNED 2018-03-20,DEVICE MANUFACTURE DATE: UNK, (B)(4), CAC200234 - CONTROLLER AC ADAPTER, CONCOMITANT MEDICAL PRODUCTS: YES, DEVICE EVALUATED BY MFR: YES, RETURNED 2018-03-20, DEVICE MANUFACTURE DATE: UNK, (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.

Description of Event or Problem · 0

LOG FILE REVIEW INDICATED THAT ONE OF THE BATTERIES ALSO HAD A COMMUNICATION ERROR.