BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12139630 · Received July 8, 2021

    Report

    Report Number
    2916596-2021-03598
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 10, 2021
    Report Date
    September 28, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED POWER ELEVATIONS WERE CONFIRMED WITHIN THE SUBMITTED LOG FILE. A SPECIFIC CAUSE FOR THESE POWER ELEVATIONS COULD NOT BE DETERMINED. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED ELEVATED LACTATE DEHYDROGENASE (LDH) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES CONFIRMED MINOR TRANSIENTLY ELEVATED POWERS, MOST OF WHICH WERE ASSOCIATED WITH PULSATILITY INDEX EVENTS AND AN INCREASE IN SET SPEED. THE SYSTEM OTHERWISE APPEARED TO FUNCTION AS INTENDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO ADDITIONAL RELATED ISSUES HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) LISTS HEMOLYSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. INFORMATION REGARDING RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO (INR) RANGE IS ALSO PROVIDED IN THIS DOCUMENT. IT ALSO EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE IFU ALSO STATES THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN PI. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. 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 II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU ADDRESSES PUMP SPEED, POWER, AND FLOW AND EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT AND THAT CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. SECTION 4 ¿SYSTEM MONITOR¿ EXPLAINS THAT PULSATILITY INDEX (PI) EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. SECTION 6 "PATIENT CARE AND MANAGEMENT" EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THIS SECTION OUTLINES INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS. THIS SECTION ALSO PROVIDES INFORMATION ON ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBUS WAS NOT CONFIRMED. THERE WERE NO CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED TO THE ISSUES. THE PUMP SPEED WAS INCREASED TO 9800. THE PATIENT HAD RAMP ECHOCARDIOGRAM ON (B)(6) 2021 AND (B)(6) 2021 WITH NO DEFINITIVE DIAGNOSIS. THE PATIENT WAS TREATED WITH BIVALIRUDIN WITH REDUCTION TO BASELINE LACTATE DEHYDROGENASE IN THE 400S. PLAN OF CARE INCLUDED RESUMING ASPIRIN AND WARFARIN. NO CAUSE FOR THE ELEVATED PUMP POWER WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURERS INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH ELEVATED LACTATE DEHYDROGENASE OF AROUND 900 WHICH WAS CONCERNING FOR THROMBOSIS. LOG FILE ANALYSIS CAPTURED A YELLOW WRENCH ALARM "REPLACE SYSTEM CONTROLLER, LCD FAULT" ON (B)(6) 2021. THE ALARMS RESOLVED ON ITS OWN AND DID NOT AFFECT THE PUMP. LOG FILE ANALYSIS CAPTURED A LOW BATTERY HAZARD ALARM DUE TO DEPLETION OF BATTERY IN (B)(6) 2021 AT 1:01 AM. UPDATED LOG FILE ANALYSIS CAPTURED A LOW VOLTAGE HAZARD DUE TO THE PATIENT RUNNING BATTERIES DOWN BELOW THE THRESHOLD. THERE WAS ALSO A LOW SPEED OPERATION DUE THE SET SPEED BEING LOWERED BELOW THE SET LOW SPEED. THERE WAS A YELLOW WRENCH/REPLACE CONTROLLER THAT WAS CAUSED BY AN LCD FAULT LATCHING ON. THE ALARM CLEARED IMMEDIATELY AND IT DID NOT NEED TO BE REPLACED. A FEW ISOLATED ELEVATED POWERS TO 8.1-8.9 WERE OBSERVED UPON INTERROGATION. LOG FILE ANALYSIS ALSO CAPTURED ELEVATED FLOWS ABOVE THE NORMAL PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033043 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 6257935 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization