HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-04552
- Event Type
- Malfunction
- Date Received
- September 25, 2018
- Date of Event
- September 13, 2018
- Report Date
- February 20, 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
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: ONE CONTROLLER, ONE AC ADAPTER, ONE DC ADAPTER AND EIGHT BATTERIES WERE RETURNED FOR EVALUATION. ONE BATTERY WAS 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. FAILURE ANALYSIS OF THE CONTROLLER REVEALED THAT THE UNIT PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED A MECHANICAL DAMAGE OF THE CABLE. THE DAMAGE THAT WAS OBSERVED DID NOT AFFECT THE FUNCTIONALITY OF THE AC ADAPTER. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT LIKELY DUE TO WEAR AND/OR TO THE HANDLING OF THE DEVICE. FAILURE ANALYSIS OF ONE BATTERY REVEALED THAT THE BATTERY PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING DUE TO A FAULTY WELD BETWEEN TWO CELL PAIRS. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE FAULTY CELL WELD CAN BE ATTRIBUTED TO TERMINAL WELDS EXPERIENCING ADDED STRESS AS A RESULT OF THE UNCONTROLLED BENDING OF THE TABS AND RESISTANCE WELDS OCCURRING ON WELD FREE ZONES. FAILURE ANALYSIS OF THE CONTROLLER, DC ADAPTER AND SEVEN BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. 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 DUE TO MOMENTARY DISCONNECTIONS. ANALYSIS OF THE EVENT FILES REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2018. THE CONTROLLER WAS WITHOUT POWER FOR 29 SECONDS. AS A RESULT, THE REPORTED POWER SWITCHING AND LOSS OF POWER EVENTS WERE CONFIRMED. BASED ON THE LOG FILE ANALYSIS, THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION OF ONE OR BOTH POWER SOURCES. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. ADDITIONAL PRODUCTS: (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.
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 ¿ AC ADAPTER / (B)(4)/ MODEL #: 1425US UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ DC ADAPTER / (B)(4)/ MODEL #: 1435, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650 / EXPIRATION DATE: 2017-06-30 UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650 / EXPIRATION DATE: 2018-06-30 UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650 / 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/ (B)(4)/ MODEL #: 1650 / EXPIRATION DATE: 2017-11-30 UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-11-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650 / EXPIRATION DATE: 2017-06-30 UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650 / 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 / (B)(4)/ MODEL #: 1650 / EXPIRATION DATE: 2017-06-30 UDI #:(B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650 / EXPIRATION DATE: 2017-06-30 UDI #:(B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2016-10-31 UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-10-31 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT POWER SWITCHING OCCURRED BETWEEN THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER AND POWER SOURCES DESPITE THE BATTERIES HAVING GREATER THAN TWENTY FIVE PERCENT CHARGE CAPACITY. IT WAS ALSO REPORTED THAT CONTROLLER EXHIBITED A LOSS OF POWER AND A PUMP STOP. THE CONTROLLER, ONE DC ADAPTER, ONE AC ADAPTER AND FOUR BATTERIES WERE EXCHANGED. FIVE BATTERIES WERE REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745452 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | 1103 VAD |