BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13834993 · Received March 20, 2022

    Report

    Report Number
    2916596-2022-01296
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    February 12, 2022
    Report Date
    May 17, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LEFT VENTRICULAR ASSIST DEVICE (LVAD) FAULT ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, PUMP STOP EVENTS WHICH APPEAR CONSISTENT WITH ELECTROSTATIC DISCHARGE (ESD) EVENTS WERE ALSO OBSERVED. THE SUBMITTED SYSTEM CONTROLLER LOG FILES CONTAIN DATA FROM (B)(6)2022 THROUGH (B)(6)2022 AND RECORDED CONSTANT LVAD FAULT ALARMS. PUMP STOP EVENTS AND CONTROLLER FAULT FLAGS WHICH APPEAR CONSISTENT WITH ESD EVENTS WERE ALSO OBSERVED ON (B)(6)2022 AND (B)(6)2022. THE LVAD FAULT ALARMS RESOLVED ON (B)(6)2022 FOLLOWING DISCONNECTION AND RECONNECTION OF THE DRIVELINE. THIS WAS ALSO LATER CONFIRMED BY THE ACCOUNT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-020596. NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ EXPLAINS THAT STRONG STATIC DISCHARGES SHOULD BE AVOIDED, AND HIGH LEVELS OF STATIC ELECTRICITY MAY DAMAGE AND/OR INTERFERE WITH THE ELECTRICAL PARTS OF THE SYSTEM, DISRUPT COMMUNICATION, AND CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. THIS SECTION INSTRUCTS THAT THE DEVICE SHOULD BE CONNECTED TO BATTERY POWER WHEN PERFORMING ACTIVITIES THAT CAN GENERATE STATIC ELECTRICITY AND LISTS SOME POSSIBLE ACTIVITIES THAT CAN GENERATE STATIC ELECTRICITY. SECTION 6 ALSO CONTAINS A SECTION ENTITLED ¿ELECTROSTATIC DISCHARGE¿ THAT LISTS WAYS TO REDUCE STATIC ELECTRICITY. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ INCLUDES ELECTROSTATIC DISCHARGE IN THE ¿SAFETY TESTING AND CLASSIFICATION¿ TABLE OF THIS DOCUMENT. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. C IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ WARNS THAT HIGH LEVELS OF STATIC ELECTRICITY MAY DAMAGE OR HARM THE SYSTEM AND MAY CAUSE YOUR PUMP TO STOP. THIS SECTION INSTRUCTS THAT THE DEVICE SHOULD BE CONNECTED TO BATTERY POWER BEFORE PERFORMING ACTIVITIES THAT CAN GENERATE STATIC ELECTRICITY AND LISTS SOME POSSIBLE ACTIVITIES THAT CAN GENERATE STATIC ELECTRICITY. SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ ALSO CONTAINS A SECTION ENTITLED ¿STATIC ELECTRICITY¿ THAT LISTS WAYS TO REDUCE STATIC ELECTRICITY. ELECTROSTATIC DISCHARGE IS INCLUDED IN THE ¿TESTING AND CLASSIFICATION¿ TABLES OF THIS DOCUMENT. THE PATIENT HANDBOOK ALSO OUTLINES ALL SYSTEM ALARMS, INCLUDING THE LVAD FAULT ADVISORY, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EVENTS IN THE ALARMS AND TROUBLESHOOTING SECTION. THIS HANDBOOK ALSO WARNS THE PATIENT TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LEFT VENTRICULAR ASSIST DEVICE (LVAD) FAULT ALARM WAS NOTED. LOG FILES CAPTURED LVAD FAULTS THROUGHOUT THE EVENT HISTORY THAT APPEARED TO BE RELATED TO COMMUNICATION WITHIN THE PUMP. TWO PUMP STOPS WERE NOTED ON (B)(6) 2022 AND (B)(6) 2022 THAT APPEARED TO BE RELATED TO THE LVAD FAULT. THE DRIVELINE WAS DISCONNECTED AND RECONNECTED AND THE ALARMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996791 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7328493 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female