BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 18528545 · Received January 17, 2024

    Report

    Report Number
    2916596-2024-00136
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 29, 2023
    Report Date
    January 31, 2024
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: ANALYSIS OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS. IT WAS REPORTED THAT THE ETIOLOGY OF THE LOW FLOW ALARMS WAS UNCLEAR; HOWEVER, SOME ALARMS OCCURRED IN THE SETTING OF HYPOVOLEMIA, WITH OTHERS LIKELY RELATED TO MINIMAL FLOW INTAKE. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM 13SEP2022 THROUGH 14SEP2022. SEVERAL LOW FLOW FAULTS WERE CAPTURED THROUGHOUT THE FILE, WHEN THE ESTIMATED FLOW DECREASED BELOW THE LOW FLOW THRESHOLD OF 2.5 LITERS PER MINUTE (LPM). THESE FAULTS RESULTED IN MULTIPLE LOW FLOW HAZARD ALARMS ON 13SEP2022 AND 14SEP2022. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HM3 LVAS, SERIAL NUMBER (B)(6) AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-033385 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 31JUL2022. THE HEARTMATE 3 LVAS IFU, REV. C, AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA AND RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE. THIS SECTION OF THE IFU ALSO EXPLAINS THAT ¿RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP.¿. SECTION 1 OF THE IFU ALSO ADDRESSES ALL PUMP PARAMETERS. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LITERS PER MINUTE (LPM), A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 4 ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDE INFORMATION ON ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. 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 TRAVELING PATIENT HAD EXPOSED DRIVELINE CABLES AT PROXIMAL SITE TO ABDOMEN. THE PATIENT WAS ASYMPTOMATIC. THE LOG FILE CAPTURED ROUTINE EVENTS, THERE WERE NO NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES. RESCUE TAPE WAS APPLIED TO THE DRIVELINE, AND THERE WERE NO REPORTED COMPLICATIONS OR ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602161 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8240058 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female