HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-01323
- Event Type
- Malfunction
- Date Received
- April 4, 2018
- Date of Event
- March 7, 2018
- Report Date
- March 5, 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
- HEALTH PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. 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.
PRODUCT EVENT SUMMARY: THE CONTROLLER (B)(4) AND FIVE (5) BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4) PASSED VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT THE BATTERY WAS RECEIVED WITH A CELL UNDER VOLTAGE (CUV)/ PACK UNDER VOLTAGE (PUV) FLAG WHICH WAS RESET TO NORMAL OPERATING CONDITIONS AFTER BEING CHARGED. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT 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). MOMENTARY DISCONNECTION WILL RESULT IN AN AUDIBLE TONE OR "BEEP". FOUR (4) CRITICAL BATTERY ALARMS WERE LOGGED INVOLVING BATTERIES (B)(4) DUE TO THE RELATIVE STATE OF CHARGE (RSOC) VALUES DEPLETING BELOW THE 10% RSOC. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE "REPORTED BEEPS" MAY BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS MAY BE ATTRIBUTED TO RSOC VALUES ALLOWED TO DEPLETE BELOW 10%. THE MOST LIKELY ROOT CAUSE OF THE INCIDENTAL CELL UNDER VOLTAGE EVENT MAY BE ATTRIBUTED TO A DEPLETION OF THE BATTERY THAT WAS NOT USED FOR AN EXTENDED PERIOD OF TIME. AN INTERNAL INVESTIGATION WAS OPENED TO EVALUATE MOMENTARY DISCONNECTIONS. 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.
ADDITIONAL PRODUCTS: BATTERY (B)(4). D10: YES, RETURN DATE: 2018-05-23 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12, 19 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-05-23 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12, 19 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-05-23 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-05-23 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-05-23 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213, 131 H6 FDA CONCLUSION CODE(S): 12, 4307 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. 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 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: 2018-08-31 UDI #:(B)(4) MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4) MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4) MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-02-28 UDI #: (B)(4) MFG DATE: 2016-02-28 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4) MFG DATE: 2017-08-31 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE CONTROLLER AND BATTERIES EXHIBITED POWER SWITCHING. THE PATIENT INDICATED THE CONTROLLER WAS BEEPING WITH ALERTS SIMILAR TO ACKNOWLEDGEMENT BEEPS THAT OCCURRED WHEN CONNECTING A BATTERY. IN ADDITION, THERE WERE SEVERAL CRITICAL BATTERY ALARMS NOTED WITHIN THE LOG FILES. THE CONTROLLER AND BATTERIES WILL BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240968 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MCS UNKNOWN VAD |