BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 7955074 · Received October 11, 2018

    Report

    Report Number
    2916596-2018-04504
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 19, 2018
    Report Date
    March 26, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE LOG FILE DATA PROVIDED BY THE ACCOUNT CONFIRMED A PUMP STOP EVENT AND CONTROLLER CLOCK RESET. THE LOG FILE PROVIDED BY THE ACCOUNT BEGAN AT TIMESTAMP (B)(6) 2018 19:17:04. THE FIXED SPEED WAS SET TO 9600RPM AND THE LOW SPEED LIMIT WAS SET AT 9000RPM. THE RECORDED DATA APPEARED TO CAPTURE THE SYSTEM OPERATING AS INTENDED FROM THE BEGINNING OF THE LOG FILE UNTIL THE TIMESTAMP FOLLOWING TIMESTAMP (B)(6) 2018 00:28:47. THE TIMESTAMP FOLLOWING TIMESTAMP (B)(6) 2018 00:28:47 REVEALED A COMPLETE LOSS OF POWER TO THE SYSTEM CONTROLLER, AS EVIDENCE FROM THE TIME CLOCK RESETTING TO THE DEFAULT MANUFACTURING TIMESTAMP OF (B)(6) 2001 AT 01:00:00. THE TOTAL LOSS OF POWER EVENT WAS PRECEDED BY LOW BATTERY ADVISORY/HAZARD AND NO EXTERNAL POWER ALARMS. THE CAPTURED ATYPICAL EVENTS AND ASSOCIATED ALARMS APPEARED INDICATIVE OF A TOTAL LOSS OF POWER TO THE SYSTEM CONTROLLER DUE TO DEPLETED BATTERIES AND SUBSEQUENT DEPLETION OF THE EMERGENCY BACKUP BATTERY. FOLLOWING THE PUMP STOPPAGE AND RESTORATION OF POWER TO THE SYSTEM VIA CHARGED EXTERNAL 14V LITHIUM-ION BATTERIES, THE PUMP RETURNED TO THE FIXED SPEED WITHOUT ISSUE. THE TIME CLOCK WAS NOT RESET FOLLOWING THE TOTAL LOSS OF POWER EVENT, RESULTING IN ACTIVE YELLOW WRENCH/CLOCK NOT SET ADVISORY ALARMS FOR THE REMAINDER OF THE LOG FILE DATA. NO OTHER ATYPICAL EVENTS WERE NOTED IN THE REMAINDER OF THE LOG FILE AND THE PUMP PARAMETERS APPEARED STABLE. THE PATIENT REMAINS ONGOING ON THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTION FOR USE AND PATIENT HANDBOOK OUTLINE ALL SYSTEM CONTROLLER ALARMS, AS WELL AS HOW TO RESPOND TO SUCH. THE DOCUMENTS ALSO PROVIDE INSTRUCTIONS FOR HOW TO CHARGE AND EXCHANGE BATTERIES, HOW TO MONITOR BATTERY CHARGE LEVEL, AND HOW TO CHANGE POWER SOURCES. BOTH DOCUMENTS STATE THAT THE PATIENT SHOULD SLEEP ONLY WHEN CONNECTED TO THE POWER MODULE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS NOT PROVIDED. APPROXIMATE AGE OF DEVICE ¿ 3 YEARS, 1 MONTH AND 26 DAYS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT THERE WAS A PUMP STOPPAGE OBSERVED ON (B)(6) 2018. THE VAD WAS EVALUATED, AND THE PERCUTANEOUS LEAD (DRIVELINE) APPEARED TO BE FINE. IT APPEARED THAT THE POWER WAS OFF AT THE HOUSE AND THE PATIENT WOKE UP WITH THE VAD OFF. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796255 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1