HEARTWARE VENTRICULAR ASSIST SYSTEM- BATTERY
Report
- Report Number
- 3007042319-2018-02879
- Event Type
- Malfunction
- Date Received
- July 6, 2018
- Date of Event
- June 12, 2018
- Report Date
- April 16, 2019
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000369
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: TWO BATTERIES (BAT305450, BAT556759) WERE NOT RETURNED FOR EVALUATION. SIX BATTERIES (BAT583284, BAT312259, BAT312260, BAT583211, BAT583256, BAT583319) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING AND VISUAL INSPECTION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENTCONTAINED 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 POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT583284. LOG FILE ANALYSIS ALSO REVEALED SEVERAL MOMENTARY DISCONNECTIONS INVOLVING BAT312260 AND BAT305450. MOMENTARY DISCONNECTION WILL RESULT IN AN AUDIBLE TONE OR "BEEP". ANALYSIS OF THE ALARM LOG FILES REVEALED TWO CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS INVOLVING BAT305450 AND BAT583284. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON JUNE 18, 2018 TO MITIGATE THE REPORTED CONDITIONS AND THE BATTERY REMAINED IN USE. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BA TTERY ALARMS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS. THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING AND BEEPS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. BATTERY BAT305450 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12, 4307 BATTERY BAT312259 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY BAT312260 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY BAT556759 H3: YES H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY BAT583211 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213. FDA CONCLUSION CODE(S): 67 BATTERY BAT583256 H3: YES H6 FDA METHOD CODE(S): 10, 4112. FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY BAT583319 H3: YES 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.
CORRECTION H6, H10: D10, H6 ADDITIONAL PRODUCTS: BATTERY BAT305450. D10: YES, RETURN DATE: (B)(6) 2019. H6: FDA METHOD CODE(S): 4114 BATTERY BAT312259. D10: YES, RETURN DATE: (B)(6) 2018 BATTERY BAT312260. D10: YES, RETURN DATE: (B)(6) 2018 BATTERY BAT583211. D10: YES, RETURN DATE: 2018 JUL 10 BATTERY BAT583256. D10: YES, RETURN DATE: (B)(6) 2018 BATTERY BAT583319. D10: YES, RETURN DATE: (B)(6) 2018. 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.
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: 2016-10-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-10-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2017-01-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-01-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2017-01-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-01-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-07-31.(B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-07-31. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CORRECTIONS: (B)(4) WAS SENT IN ERROR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) BATTERIES POST SERVICING EXHIBITED POWER SWITCHING AND INAPPROPRIATE CRITICAL BATTERY ALARMS. THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509191 | HEARTWARE VENTRICULAR ASSIST SYSTEM- BATTERY | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1650DE | 00888707000369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | 1103 VAD. |