HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-00196
- Event Type
- Malfunction
- Date Received
- January 12, 2018
- Date of Event
- December 27, 2017
- Report Date
- October 2, 2018
- 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
- SW
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
CORRECTION: H8. ADDITIONAL PRODUCTS: BATTERY, (B)(4). D10: YES, RETURN DATE: 2018-01-24 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGAN H6: RESULTS CODE: 3233 H6: CONCLUSION CODE: 11 ADDITIONAL PRODUCTS: D4: BATTERY, (B)(4)/ MODEL #: 1650DE D10: YES, RETURN DATE: 2018-01-24 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGAN H6: RESULTS CODE: 3233 H6: CONCLUSION CODE: 11 ADDITIONAL PRODUCTS: BATTERY, (B)(4). D10: YES, RETURN DATE: 2018-01-24 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGAN H6: RESULTS CODE: 3233 H6: CONCLUSION CODE: 11 ADDITIONAL PRODUCTS: BATTERY, (B)(4). D10: YES, RETURN DATE: 2018-01-24 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGAN H6: RESULTS CODE: 3233 H6: CONCLUSION CODE: 11 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 2.0 CONTROLLER PASSES VISUAL INSPECTION AND FUNCTIONAL TESTING. ADDITIONAL PRODUCTS: BATTERY, (B)(4). H3: YES H6: FDA METHOD CODE(S): 10, 23, 38, 3372 H6: FDA RESULTS CODE(S):213 H6: FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. ADDITIONAL PRODUCTS: BATTERY, (B)(4). H3: YES H6: FDA METHOD CODE(S): 10, 23, 38, 3372 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. ADDITIONAL PRODUCTS: BATTERY, (B)(4). H3: YES H6: FDA METHOD CODE(S): 10, 23, 38, 3372 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. ADDITIONAL PRODUCTS: BATTERY, (B)(4). H3: YES H6: FDA METHOD CODE(S): 10, 23, 38, 3372 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL 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 FOUR BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. TWO BATTERIES (B)(4) 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. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE 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 MOMENTARY DISCONNECTIONS INVOLVING (B)(4). MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE OR ¿BEEP¿. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MANUFACTURER IS INVESTIGATING MOMENTARY DISCONNECTIONS. (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. 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.
IT WAS FURTHER REPORTED THAT BATTERIES (B)(4) AND (B)(4) WERE NOT ASSOCIATED WITH THIS EVENT.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-06-30, (B)(4), MFG DATE: 2017-06-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4)/ MODEL #: XXXX / EXPIRATION DATE: 2018-06-30 UDI #: (B)(4), MFG DATE: 2017-06-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-06-30 UDI #: (B)(4), MFG DATE: 2017-06-30, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-06-30 UDI #: (B)(4), MFG DATE: 2017-06-30, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-06-30 UDI #: (B)(4), MFG DATE: 2017-06-30, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4) / MODEL #:1650DE / EXPIRATION DATE: 2018-06-30 UDI #: (B)(4), MFG DATE: 2017-06-30, (B)(4). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED FOR THE SITE, PATIENT EXPERIENCING SEVERAL BEEPS FROM THE CONTROLLER. AFTER SPEAKING WITH A MEDTRONIC CLINICAL SPECIALIST, IT WAS SUGGESTED TO CHANGE OUT THE CONTROLLER AND BATTERIES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29842 | HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4). |