HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2017-03377
- Event Type
- Malfunction
- Date Received
- September 26, 2017
- Date of Event
- August 29, 2017
- Report Date
- October 25, 2018
- 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
PRODUCT EVENT SUMMARY #THE CONTROLLER (B)(4), THREE CONTROLLER AC ADAPTORS (B)(4) AND FIVE BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES, CONTROLLER AND CONTROLLER AC ADAPTERS REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS FOR CONTROLLER (B)(4) REVEALED THAT THIS CONTROLLER WAS IN USE DURING THE REPORTED EVENT AND 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)(4). IN ADDITION, ANALYSIS OF THE DATA FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). BASED ON THE INVESTIGATION CONDUCTED, 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. AN INTERNAL INVESTIGATION IS EVALUATING MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: BATTERY - (B)(4). H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 BATTERY - (B)(4). H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 BATTERY - (B)(4). H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 BATTERY - (B)(4). H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 BATTERY - (B)(4). H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 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.
DEVICE ANALYSIS, CON302012: THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ADDITIONAL PRODUCTS: BATTERY - BAT208205 D10: YES, RETURN DATE: 2017-09-19 H3: YES H4: MFG DATE: 2015-09-11 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 DEVICE ANALYSIS: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY - BAT213015 D10: YES, RETURN DATE: 2017-09-19 H3: YES H4: MFG DATE: 2015-12-22 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 DEVICE ANALYSIS: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY - BAT217660 D10: YES, RETURN DATE: 2017-09-21 H3: YES H4: MFG DATE: 2016-04-15 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 DEVICE ANALYSIS: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY - BAT205116 D10: YES, RETURN DATE: 2017-09-21 H3: YES H4: MFG DATE: 2015-02-03 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 DEVICE ANALYSIS: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY - BAT212413 D10: YES, RETURN DATE: 2017-09-19 H3: YES H4: MFG DATE: 2015-12-18 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 DEVICE ANALYSIS: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THIS REPORT WAS IDENTIFIED FOLLOWING THE CONVERSION OF COMPLAINT FILES FROM THE LEGACY COMPLAINT HANDLING SYSTEM FOLLOWING INTEGRATION AND IS BEING SUBMITTED TO REPORT ANALYSIS RESULTS. 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL DEVICES FOR THIS COMPLAINTS: COMMON DEVICE NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. SERIAL: (B)(4)- BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 09/30/2016. DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR: NO, NOT RETURNED TO MANUFACTURER . LABELED FOR SINGLE USE: NO . (B)(4). COMMON DEVICE NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. SERIAL: (B)(4)- BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 12/31/2016. DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR: NO, NOT RETURNED TO MANUFACTURER . LABELED FOR SINGLE USE: NO . (B)(4). COMMON DEVICE NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. SERIAL: (B)(4)- BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 12/31/2016. DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR: NO, NOT RETURNED TO MANUFACTURER . LABELED FOR SINGLE USE: NO . (B)(4). COMMON DEVICE NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. SERIAL: (B)(4)- BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 02/29/2016. DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR: NO, NOT RETURNED TO MANUFACTURER . LABELED FOR SINGLE USE: NO . (B)(4). COMMON DEVICE NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. SERIAL: (B)(4)- BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 12/31/2016. DEVICE AVAILABLE FOR EVALUATION?: NO. DEVICE EVALUATED BY MFR: NO, NOT RETURNED TO MANUFACTURER . LABELED FOR SINGLE USE: NO . (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
OTHER DEVICES INVOLVED IN THIS EVENT: MEDICAL DEVICE: BATTERY / (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
IT WAS REPORTED THAT THE CONTROLLER EXHIBITED UNDEFINED POWER SWITCHING. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675512 | HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | CIRCULATORY ASSIST SYSTEM, | DSQ | HEARTWARE, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTROLLER AC ADAPTER - (B)(4)| CONTROLLER AC ADAPTER - (B)(4)| CONTROLLER AC ADAPTER - (B)(4)| PUMP - (B)(4) |