HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-00076
- Event Type
- Malfunction
- Date Received
- January 4, 2018
- Date of Event
- November 22, 2017
- Report Date
- August 13, 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
- NURSE
Narratives
CORRECTIONS: H2, H3, H10: D10 WERE CORRECTED FOR SUPPLEMENTAL 001 OTHER DEVICES INVOLVED IN THIS EVENT: BATTERY (B)(4). D10: 2018-02-05 BATTERY (B)(4). D10: 2018-02-05 BATTERY (B)(4). D10: 2018-02-05 BATTERY (B)(4). D10: 2018-02-05 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.
CORRECTION: ORIGINAL DATE MFR REC: G4: 2017-12-11 PRODUCT EVENT SUMMARY #THE CONTROLLER (CON300739) AND BATTERIES (BAT220197, BAT219039, BAT220348, BAT220019) WERE RETURNED FOR EVALU ATION. 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 FUNCTIONAL TESTING. THE RETURNED BATTERIES PASSED VISUAL INSPECTION. VISUAL INSPECTION OF CONTROLLER UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACK AROUND POWER PORT 1 AND 2. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACKS WERE NOT RELATED TO THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, CON300739, 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 EVENTSTHAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT219039 AND BAT220348 AND POWER SWITCHING EVENT DUE TO COMMUNICATION ERROR INVOLVING BAT219039. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. ALARM LOG FILE REVEALED ONE CRITICAL BATTERY ALARM DUE TO COMMUNICATION ERROR INVOLVING BATTERY BAT220348. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. ADDITIONAL PRODUCTS: BATTERY BAT220197 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 ADDITIONAL PRODUCTS: BATTERY BAT219039 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12, 4307 ADDITIONAL PRODUCTS: BATTERY BAT220348 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12, 4307 ADDITIONAL PRODUCTS: BATTERY BAT220019 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 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.
CORRECTIONS: B3, B5, E1, E3, G4, H10 PRODUCT EVENT SUMMARY: THE CONTROLLER (CON300739) AND FOUR BATTERIES (BAT220197, BAT219039, BAT220348, BAT220019) 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 FUNCTIONAL TESTING. THE RETURNED BATTERIES PASSED VISUAL INSPECTION. VISUAL INSPECTION OF THE CONTROLLER UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACK AROUND POWER PORT 1 AND 2. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACKS WERE NOT RELATED TO THE REPORTED EVENT. AN INVESTIGATION WAS OPENED TO INVESTIGATE CRACKS OBSERVED ON PIONEER 2.0, IN THE AREA SURROUNDING THE POWER PORT CONNECTORS. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, CON300739, 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 BAT219039 AND BAT220348 AND POWER SWITCHING EVENT DUE TO COMMUNICATION ERROR INVOLVING BAT219039. ADDITIONALLY, DATA LOG FILES REVEALED A RELATIVE STATE OF CHARGE (RSOC) BETWEEN 101-201 IN VOLVING BAT219039, BAT220348, BAT220019, WHICH IS INDICATIVE OF A COMMUNICATION ERROR. ALARM LOG FILE REVEALED ONE CRITICAL BATTERY ALARM DUE TO COMMUNICATION ERROR INVOLVING BATTERY BAT220348. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. 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 EXAMINED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D4: SERIAL#: BAT220019 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 4307 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.
(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
LOGFILE REVIEW INDICATED THAT THREE OF THE BATTERIES ALSO HAD COMMUNICATION ERRORS.
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: BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30 UDI #: (B)(4) MFG DATE: 2016-06-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30 UDI #: (B)(4): MFG DATE: 2016-06-30 (B)(4).: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30 UDI #:(B)(4), MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY : BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30 UDI #: (B)(4) MFG DATE: 2016-06-30. (B)(4).
CORRECTED FOR CONTROLLER AND ALL BATTERIES. SERIAL: (B)(4)- BATTERY. DEVICE AVAILABLE FOR EVALUATION: YES - RETURNED DATE: 2018-02-14, SERIAL: (B)(4)- BATTERY, DEVICE AVAILABLE FOR EVALUATION: YES - RETURNED DATE: 2018-02-14,SERIAL: (B)(4)- BATTERY, DEVICE AVAILABLE FOR EVALUATION: YES - RETURNED DATE: 2018-02-14, SERIAL: (B)(4)- BATTERY, DEVICE AVAILABLE FOR EVALUATION: YES - RETURNED DATE: 2018-02-14. PRELIMINARY ANALYSIS INDICATED THAT THE CONTROLLER FAILED EXTERNAL VISUAL INSPECTION AND PASSED FUNCTIONAL TESTING. THE RETURNED BATTERIES PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE CONTROLLER AND BATTERIES EXHIBITED POWER SWITCHING DESPITE BATTERY CAPACITIES GREATER THAN TWENTY-FIVE PERCENT (25%). THE CONTROLLER AND BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE PATIENT ALSO RECEIVED CRITICAL BATTERY ALARMS DESPITE FULLY CHARGED BATTERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6944 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1420-CONTROLLER | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | 1104 VAD |