HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER.
Report
- Report Number
- 3007042319-2017-00194
- Event Type
- Malfunction
- Date Received
- January 20, 2017
- Date of Event
- December 12, 2016
- Report Date
- December 14, 2018
- Manufacturer
- HEARTWARE, INC
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UPDATED SECTIONS: D1, G4, G7, H2, H3, H6, H7, H9 AND H10. (B)(6)-CATALOG #-1650DE, EXP DATE- 03/31/2016. UDI #: UNK. H3: NO, NOT RETURNED TO MANUFACTURER. H4: 03/31/2015 H5: NO H6: METHOD COD(S):ANALYSIS OF DATA LOG(S) C102867; FDA 3372; MANUFACTURING REVIEW C91960; FDA 3317; ACTUAL DEVICE NOT EVALUATED C91897; FDA 3263. RESULTS CODE(S): INTEROPERABILITY PROBLEM C92070; FDA 3213. CONCLUSION CODE(S): DEVICE NOT RETURNED C91883; FDA 92; QUALITY SYSTEM DEFICIENCY C91885; FDA 25. (B)(6)- CATALOG #- 1650DE, EXP DATE-12/31/2016 UDI #: UNK. D10: NO. H3: NO, NOT RETURNED TO MANUFACTURER. H4: 12/31/2015. H5: NO. H6: METHOD COD(S):ANALYSIS OF DATA LOG(S) C102867; FDA 3372; MANUFACTURING REVIEW C91960; FDA 3317; ACTUAL DEVICE NOT EVALUATED C91897; FDA 3263. RESULTS CODE(S): INTEROPERABILITY PROBLEM C92070; FDA 3213. CONCLUSION CODE(S): DEVICE NOT RETURNED C91883; FDA 92; QUALITY SYSTEM DEFICIENCY C91885; FDA 25. (B)(6)- CATALOG#- 1650DE, EXP DATE-01/31/2017 UDI #: UNK. D10: NO. H3: NO, NOT RETURNED TO MANUFACTURER. H4: 01/31/2016 H5: NO. H6: METHOD COD(S):ANALYSIS OF DATA LOG(S) C102867; FDA 3372; MANUFACTURING REVIEW C91960; FDA 3317; ACTUAL DEVICE NOT EVALUATED C91897; FDA 3263. RESULTS CODE(S): INTEROPERABILITY PROBLEM C92070; FDA 3213. CONCLUSION CODE: DEVICE NOT RETURNED C91883; FDA 92; QUALITY SYSTEM DEFICIENCY C91885; FDA 25. D4: BATTERY/B)(6)/ CATALOG NUMBER: 1650 / EXPIRATION DATE:04/30/2016. UDI #: UNK. D10: NO. H3: NO, NOT RETURNED TO MANUFACTURER. H4: 04/30/2015. H5: NO H6: METHOD COD(S):ANALYSIS OF DATA LOG(S) C102867; FDA 3372; MANUFACTURING REVIEW C91960; FDA 3317; ACTUAL DEVICE NOT EVALUATED C91897; FDA 3263. RESULTS CODE(S): INTEROPERABILITY PROBLEM C92070; FDA 3213. CONCLUSION CODE: DEVICE NOT RETURNED C91883; FDA 92; QUALITY SYSTEM DEFICIENCY C91885; FDA 25. D4: BATTERY/(B)(6)/ CATALOG NUMBER: 1650 / EXPIRATION DATE:04/30/2016. UDI #: UNK. D10: 02/16/2017. H3: YES, RETURNED TO MANUFACTURER. H4: 04/30/2015. H5: NO H6: METHOD CODE(S): VISUAL INSPECTION C92023; FDA 38; ANALYSIS OF DATA LOG(S) C102867; FDA 3372; INTEROPERABILITY EVALUATION C91951; FDA 20; ACTUAL DEVICE EVALUATED C91896; FDA 10. RESULTS CODE: INTEROPERABILITY PROBLEM C92070; FDA 3213. CONCLUSION CODE: QUALITY SYSTEM DEFICIENCY C91885; FDA 25. IT WAS REPORTED POWER SWITCHING EVENTS, A REAL TIME CLOCK ERROR, BATTERY STATUS LED NOT ABLE TO BE DISPLAYED ON THE CONTROLLER, BATTERY CAPACITY NOT ABLE TO BE DISPLAYED ON THE MONITOR AND THE "NO POWER" ALARM NOT ABLE TO BE TURNED OFF. THE CONTROLLER ((B)(6)) AND ONE BATTERY ((B)(6)) WERE RETURNED FOR EVALUATION. FOUR BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE NON-RETURNED BATTERIES MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED THE SMR SOFTWARE. THE SOFTWARE UPGRADE CONTAINS A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. LOG FILE ANALYSIS PERTAINING TO (B)(6) WERE ANALYZED AND REVEALED THAT THE PATIENT EXPERIENCED MULTIPLE POWER SWITCHING EVENTS INVOLVING (B)(6) BEFORE THE REPORTED EVENT DATE. THESE PREMATURE SWITCHING EVENTS ARE DUE TO MOMENTARY DISCONNECTIONS BETWEEN BATTERY AND CONTROLLER. A REVIEW OF THE ALARM LOG FILES SHOWS THAT THE REAL TIME CLOCK (RTC) STOPPED WORKING. FAILURE ANALYSIS OF THE RETURNED BATTERY REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE UNIT PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING AS IT WAS UNABLE TO DISPLAY BATTERY CAPACITIES. THE REPORTED INABILITY TO SILENCE THE "NO POWER" ALARM WITH AN ALARM ADAPTER COULD NOT BE CONFIRMED; CONNECTING AN ALARM ADAPTER TO THE SERIAL PORT PREVENTED THE "NO POWER" ALARM FROM SOUND WHEN BOTH POWER SOURCES WERE DISCONNECTED. INTERNAL INSPECTION OF THE CONTROLLER REVEALED A DAMAGED TRANSIENT VOLTAGE SUPPRESSOR (TVS) DIODE ON THE COMMUNICATION LINE. A TVS DIODE IS DESIGNED TO PROTECT SENSITIVE COMPONENTS FROM SUDDEN VOLTAGE SPIKES. INTERNAL INSPECTION OF THE CONTROLLER ALSO REVEALED THAT THE INTEGRATED CIRCUIT (IC) RESPONSIBLE FOR THE COMMUNICATION BETWEEN THE CONTROLLER AND BATTERIES WAS DAMAGED, LIKELY DUE TO THE DAMAGED DIODE. THE DAMAGED INTEGRATED CIRCUIT IS ALSO CONNECTED TO THE REAL TIME CLOCK CIRCUIT AND MAY HAVE CAUSED THE DATE AND TIME STAMP TO REMAIN FROZEN. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A MISALIGNMENT OF THE CAC ADAPTER ON ONE CONTROLLER POWER PORT OF THE CONTROLLER, CAUSING A VOLTAGE SPIKE ON THE COMMUNICATION PIN OF THE CONNECTOR. THIS LIKELY DAMAGED THE TRANSIENT VOLTAGE SUPPRESSOR DIODE AND AN INTEGRATED CIRCUIT. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PER FDA REQUEST, THIS FOLLOW-UP REPORT WAS ELECTRONICALLY RESUBMITTED. ALL RELEVANT SUBSTANTIVE INFORMATION WAS PREVIOUSLY SUBMITTED. 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.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED SECTIONS G4, G7, H2, H3 AND H10 HAVE BEEN UPDATED ACCORDINGLY. B5- ADDITIONAL INFORMATION RECEIVED (01/09/2017) INDICATED THAT THIS WAS THE PATIENT'S PRIMARY CONTROLLER. THE PATIENT DENIED LOSS OF POWER AND ANY REPORTS OF DROPPING OR DAMAGE TO THE CONTROLLER UNIT. IN ADDITION, THE PATIENT DENIED EXPERIENCING ANY FURTHER ISSUES WITH SWITCHING OR CONNECTIONS SINCE THE CONTROLLER EXCHANGE. PRELIMINARY LOG FILE ANALYSIS REVEALED ADDITIONAL BATTERIES INVOLVED IN THE POWER SWITCHING INCIDENT. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: (B)(6)-CAT LOG- 1650DE, EXP DATE- 03/31/2016. (B)(6)- CAT LOG- 1650DE, EXP DATE-12/31/2016. (B)(6)- CAT LOG- 1650DE, EXP DATE-01/31/2017. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED SECTIONS D1, G4, G7, H2, H3 AND H10 HAVE BEEN UPDATED ACCORDINGLY. B5--LOG FILE ANALYSIS REVEALED THE INVOLVEMENT OF (B)(6) IN POWER SWITCHING INCIDENTS. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: D4: BATTERY/(B)(6)/ CATALOG NUMBER: 1650 / EXPIRATION DATE:04/30/2016. UDI #: UNK. D10: NO. H3: NO, NOT RETURNED TO MANUFACTURER. H4: 04/30/2015. H5: NO. H6: FDA DEVICE CODE: BATTERY ISSUE C63030; FDA 2885 D4: BATTERY/(B)(6)/ CATALOG NUMBER: 1650 / EXPIRATION DATE:04/30/2016. UDI #: UNK. D10: 02/16/2017. H3: YES RETURNED TO MANUFACTURER. H4: 04/30/2015. H5: NO. H6: FDA DEVICE CODE: BATTERY ISSUE C63030; FDA 2885 (B)(6) WAS RETURNED UNDER ANOTHER REPORT THAT WAS NOT REPORTABLE, NO MFR# GIVEN. ((B)(4)). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
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.
CORRECTED SECTION H6 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 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. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. PRODUCT HAS BEEN NOT RETURN.
IT WAS REPORTED THAT THE PATIENT'S CONTROLLER CHANGED FROM ONE POWER PORT TO THE OTHER ONE BEFORE BATTERIES WERE DOWN TO 25%. THE CONTROLLER'S DATE WAS ALSO INCORRECTLY SET TO 03/03/99. IN ADDITION, THE PATIENT ALSO COMPLAINED THAT BOTH BATTERY STATUS LIGHTS DID NOT ILLUMINATE ON THE CONTROLLER DISPLAY, THE BATTERY CAPACITY LIGHTS DID NOT DISPLAY ON THE MONITOR, AND THE "NO POWER" ALARM COULD NOT BE TURNED OFF WITH THE ALARM ADAPTER. LOG FILES WERE SENT AND THE CONTROLLER WAS EXCHANGED WITHOUT CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51322 | HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER. | CIRCULATORY ASSIST SYSTEM | DSQ | HEARTWARE, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |