HEARTWARE VENTRICULAR ASSIST SYSTEM
Report
- Report Number
- 3007042319-2017-02250
- Event Type
- Malfunction
- Date Received
- July 19, 2017
- Date of Event
- June 22, 2017
- Report Date
- October 4, 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
FOR (B)(4)/1407DE . BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2015-12-31; MFG. DATE: 2014-12-04. (PRODUCT RECEIVED ON: 2017-08-24). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2015-12-31; MFG. DATE: 2014-12-31. (PRODUCT NOT RECEIVED ON). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2015-12-31; MFG. DATE: 2014-12-05. (PRODUCT RECEIVED ON: 2017-08-24). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2015-12-31; MFG. DATE: 2014-12-08. (PRODUCT RECEIVED ON: 2017-08-15). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2015-12-31; MFG. DATE: 2014-12-02. (PRODUCT RECEIVED ON: 2017-08-23). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2015-12-31; MFG. DATE: 2014-12-04. (PRODUCT RECEIVED ON: 2017-08-22). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: UNK; MFG. DATE: UNK. (PRODUCT RECEIVED ON: 2017-11-22). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2018-01-31; MFG. DATE: 2017-01-31. (PRODUCT RECEIVED ON: 2017-11-22). DI# (B)(4). BATTERY/ (B)(4); MODEL 1650DE; EXP. DATE: 2018-02-28; MFG. DATE: 2017-02-28. (PRODUCT RECEIVED ON: 2017-11-07). DI# (B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED POWER SWITCHING EVENTS. THE CONTROLLER ((B)(4)) AND EIGHT BATTERIES ((B)(4)) WERE RETURNED FOR EVALUATION. ONE BATTERY ((B)(4)) WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE CONTROLLER AND NON-RETURNED BATTERY¿S MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE (B)(4) REVEALED THAT DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF (B)(4) REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION; HOWEVER, FUNCTIONAL TESTING REVEALED THAT THE BATTERIES FLASHED RED ON THE BATTERY CHARGER DUE TO A HIGH MAX ERROR. THE MAX ERROR IS AN INDICATOR OF HOW WELL THE BATTERIES' RELATIVE STATE OF CHARGE (RSOC) ARE CALIBRATED. THE BATTERY ARE STILL ABLE TO CHARGE AND PROVIDE POWER TO A CONTROLLER. A TENDENCY TO EXCHANGE BATTERIES BEFORE REACHING 25% RELATIVE STATE OF CHARGE (RSOC) MAY CONTRIBUTE TO AN OUT-OF-CALIBRATION CONDITION. THIS OBSERVATION IS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE BATTERIES FLASHING RED CAN BE ATTRIBUTED TO BATTERIES THAT ARE OUT OF CALIBRATION. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF THE CONTROLLER REVEALED A LOOSE POWER PORT 1 CONNECTOR. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED THE MOST LIKELY ROOT CAUSE OF THE LOOSE CONNECTOR CAN BE ATTRIBUTED TO INADEQUATE THREAD LOCK, AN INCONSISTENT THREAD LOCK CURE TIME AND AN INADEQUATE TORQUE APPLICATION DURING THE ASSEMBLY PROCESS. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), CONTAINED THE SMR SOFTWARE. THE SOFTWARE UPGRADE CONTAINS 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). THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE MOMENTARY DISCONNECTIONS. THE MANUFACTURER HAS OPENED AN INVESTIGATION WITH THE SUPPLIER TO EVALUATE LOOSE COMPONENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY: THE CONTROLLER ((B)(4)) AND NINE BATTERIES ((B)(4)) WERE RETURNED FOR EVALUATION. A REVIEW OF THE CONTROLLER AND (B)(4) MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF (B)(4) REVEALED THAT DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF (B)(4) REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION; HOWEVER, FUNCTIONAL TESTING REVEALED THAT THE BATTERIES FLASHED RED ON THE BATTERY CHARGER DUE TO A HIGH MAX ERROR. THE MAX ERROR IS AN INDICATOR OF HOW WELL THE BATTERIES' RELATIVE STATE OF CHARGE (RSOC) ARE CALIBRATED. THE BATTERIES ARE STILL ABLE TO CHARGE AND PROVIDE POWER TO A CONTROLLER. A TENDENCY TO EXCHANGE BATTERIES BEFORE REACHING 25% RELATIVE STATE OF CHARGE (RSOC) MAY CONTRIBUTE TO AN OUT-OF-CALIBRATION CONDITION. FAILURE ANALYSIS OF (B)(4) REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION; HOWEVER, FUNCTIONAL TESTING REVEALED THAT A CELL PAIR DID NOT HAVE SUFFICIENT VOLTAGE. SUPPLEMENTAL TESTING REVEALED THAT THE CELL PAIR'S BATTERY CAN (CONTAINER) WAS FOUND PERFORATED. ADDITIONALLY, CORROSION WAS FOUND DUE TO THE INTERNAL ELECTROLYTE LEAKING. THIS OBSERVATION MOST LIKELY OCCURRED DURING THE WELDING PROCESS. FAILURE ANALYSIS OF THE RETURNED CONTROLLER ((B)(4)) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF THE CONTROLLER REVEALED A LOOSE POWER PORT 1 CONNECTOR. THE BATTERIES FLASHING RED, BATTERY PERFORATED CELL, AND CONTROLLER LOOSE CONNECTOR ARE ADDITIONAL OBSERVATIONS NOT RELATED TO THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), CONTAINS 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). AS A RESULT, THE REPORTED POWER SWITCHING EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE BATTERIES FLASHING RED CAN BE ATTRIBUTED TO BATTERIES THAT ARE OUT OF CALIBRATION. THE MOST LIKELY ROOT CAUSE OF THE FAULTY BATTERY CELL CAN BE ATTRIBUTED TO A PERFORATION OF THE CELL; THE MOST LIKELY ROOT CAUSE OF THE LOOSE CONNECTOR ON THE CONTROLLER CAN BE ATTRIBUTED TO INADEQUATE THREAD LOCK, AN INCONSISTENT THREAD LOCK CURE TIME, AND AN INADEQUATE TORQUE APPLICATION DURING THE ASSEMBLY PROCESS. - AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS MOMENTARY DISCONNECTIONS. - AN INTERNAL INVESTIGATION HAS BEEN OPENED BY THE SUPPLIER TO INVESTIGATE PERFORATED CELLS DURING THE WELDING PROCESS. MEDICAL DEVICE INFORMATION: (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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
COMMON DEVICE NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. MODEL #: BAT510323 - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 01/31/2018 (B)(4). 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. MODEL #: BAT510390 - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 01/31/2018 (B)(4). 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. MODEL #: BAT510703 - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 02/28/2018. (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO . (B)(4). AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED HAVE BEEN UPDATED ACCORDINGLY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
ADDITIONAL DEVICES FOR THIS COMPLAINTS: (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE:12/31/2015, (B)(4), DEVICE AVAILABLE FOR EVALUATION?: NO, NO, NOT RETURNED TO MANUFACTURER, LABELED FOR SINGLE USE?: NO, (B)(4). (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE:12/31/2015, DEVICE AVAILABLE FOR EVALUATION?: NO, NO, NOT RETURNED TO MANUFACTURER, LABELED FOR SINGLE USE?: NO, (B)(4). (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE:12/31/2015, DEVICE AVAILABLE FOR EVALUATION?: NO, NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO, (B)(4). (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE:12/31/2015, DEVICE AVAILABLE FOR EVALUATION?:: NO, NO, NOT RETURNED TO MANUFACTURER, LABELED FOR SINGLE USE?: NO, (B)(4). (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE:12/31/2015, DEVICE AVAILABLE FOR EVALUATION?: NO, NO, NOT RETURNED TO MANUFACTURER, LABELED FOR SINGLE UES?: NO, (B)(4). (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE:12/31/2015, DEVICE AVAILABLE FOR EVALUATION?: NO, NO, NOT RETURNED TO MANUFACTURER, LABELED FOR SINGLE USE?: NO, (B)(4). THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. THE CONTROLLER IS A MICROPROCESSOR UNIT THAT CONTROLS AND MANAGES THE SYSTEM. IT SENDS POWER AND OPERATING SIGNALS TO THE BLOOD PUMP AND COLLECTS INFORMATION FROM THE PUMP. THE CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION: EITHER TWO BATTERIES, OR ONE BATTERY AND AN AC ADAPTER OR DC ADAPTER. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. THEY ALSO OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. IT IS OUTLINED TO INSPECT THE POWER CONNECTIONS AND PINS ONCE A WEEK, ONE AT A TIME WHEN CHANGING THE POWER SOURCE. THE IFU FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIMES. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. THE DEVICE LABELING WARNS THAT DISCONNECTING THE CONTROLLER FROM THE DRIVELINE AND DISCONNECTING BOTH POWER SOURCES (BATTERIES AND AC OR DC ADAPTER) AT THE SAME TIME WILL STOP THE PUMP. AT LEAST ONE POWER SOURCE MUST BE CONNECTED AT ALL TIMES. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
IT WAS REPORTED THAT THERE WAS POWER SWITCHING ON THE CONTROLLER. THE CONTROLLER AND 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 |
|---|---|---|---|---|---|---|---|
| 507369 | HEARTWARE VENTRICULAR ASSIST SYSTEM | CIRCULATORY ASSIST SYSTEM, BATTERY | DSQ | HEARTWARE, INC | 1407DE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MCS UNKNOWN VAD |