BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, US, EP

    MDR report key: 9728046 · Received February 19, 2020

    Report

    Report Number
    2916596-2020-00933
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    January 31, 2020
    Report Date
    April 14, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT A COMPLETE LOSS OF POWER WAS CONFIRMED BASED ON THE INFORMATION RECORDED IN THE PROVIDED LOG FILE. THE INFORMATION CONTAINED IN THE LOG FILE REVEALED THE SYSTEM MAINTAINED THE DESIRED SET SPEED WITH NO INTERRUPTIONS FROM THE TIME STAMP OF DAY 1134, 23 HOURS AND 11 MINUTES TO DAY 1136, 6 HOURS AND 50. THERE WERE INTERMITTENT LOW VOLTAGE ADVISORY ALARMS WHEN CONNECTED TO 14V BATTERIES. THE DATA RECORDED ON DAY 1136, 6 HOURS AND 50 MINUTES REVEALED THAT THE CONTROLLER WAS CONNECTED TO A POWER MODULE AND THERE WAS A POWER CABLE DISCONNECT ALARM FOLLOWED BY A COMPLETE LOSS OF POWER. THE NEXT RECORDED ENTRY, AFTER THE POWER WAS RESTORED, REVEALED THAT THE SYSTEM RESUMED PROPER OPERATION AT THE DESIRED SET SPEED AND THE CLOCK WAS RESET TO 0 DAYS, 0 HOURS AND 0 MINUTES. A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT WAS NOT ABLE TO BE DETERMINED. THE SYSTEM CONTROLLER WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER WAS NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HANDBOOK HEART MATE II PATIENT HANDBOOK PROVIDES INSTRUCTIONS FOR EXCHANGING POWER SOURCES AND WARNS THAT AT LEAST ONE SYSTEM CONTROLLER POWER LEAD MUST BE CONNECTED TO A POWER SOURCE AT ALL TIMES. IF BOTH POWER LEADS ARE DISCONNECTED AT THE SAME TIME, THE PUMP WILL STOP. THE PATIENT HANDBOOK ALSO CONTAINS AN EMERGENCY RESPONSE CHECKLIST. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED, BUT WILL BE REQUESTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2020-00573. IT WAS REPORTED THAT LOG FILES WERE SENT FOR REVIEW. THE PATIENT WAS TRANSFERRED FROM REHABILITATION WITH NO EXTERNAL POWER HOOKED TO HER CONTROLLER. THE MANUFACTURER'S TECHNICAL SERVICES REVIEWED THE LOG FILE AND OBSERVED A PUMP STOP EVENT DUE TO THE SYSTEM CONTROLLER LOSING TOTAL POWER. APPEARED THAT THE PATIENT WAS USING THE POWER MODULE AT THE TIME. CUSTOMER WAS UNABLE TO TELL HOW LONG THE PUMP WAS OFF DUE TO THE EPC CONTROLLER NOT HAVING A TRUE DATE STAMP. THE PATIENT DID NOT HAVE A BACKUP BATTERY TO POWER THE PUMP LIKE THE POCKET CONTROLLER. THE PATIENT WAS RECONNECTED TO THE POWER MODULE AND THE PUMP RESTARTED. PRIOR TO THE PUMP STOP THE LOG CAPTURED LONG ODD STRINGS OF LOW VOLTAGE EVENTS WHILE USING BATTERY POWER ONLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190485 HEARTMATE II SYSTEM CONTROLLER, US, EP VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention HEARTMATE II LVAS IMPLANT KIT, SERIAL#: (B)(6)