BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 5728190 · Received June 15, 2016

    Report

    Report Number
    2916596-2016-01123
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 18, 2016
    Report Date
    May 18, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE TRACKING INFORMATION REVEALED THAT THE RETURNED BACKUP SYSTEM CONTROLLER WAS ORIGINALLY SHIPPED TO A DIFFERENT HOSPITAL. THE HOSPITAL WAS CONSULTED AND IT WAS REPORTED THAT IT COULD NOT BE DETERMINED WHEN THE SYSTEM CONTROLLER WAS GIVEN TO THE PATIENT AS A BACKUP. IT WAS REPORTED THAT THE HOSPITAL USED TO KEEP BACKUP SYSTEM CONTROLLERS FROM PATIENTS THAT HAD BEEN TRANSPLANTED OR EXPIRED AS BACKUP HOSPITAL STOCK. IT WAS REPORTEDLY POSSIBLE THAT ONE OF THESE HOSPITAL STOCK SYSTEM CONTROLLERS WAS GIVEN TO THE PATIENT AS A BACKUP. IT WAS REPORTED THAT THE HOSPITAL HAS STOPPED THIS PRACTICE AND ALL SYSTEM CONTROLLERS ARE SINGLE-USE ONLY NOW AS PER DEVICE LABELING. THE DATA LOG FILE RETRIEVED FROM THE RETURNED BACKUP SYSTEM CONTROLLER CAPTURED MULTIPLE EVENTS WHERE THE PUMP SPEED DROPPED BELOW THE LOW SPEED LIMIT, AND WAS AS LOW AS 0 RPM. THE BACKUP SYSTEM CONTROLLER APPEARED TO HAVE STRUGGLED TO OPERATE THE PUMP IT WAS CONNECTED TO DURING THESE EVENTS WITH ELEVATIONS IN PUMP POWER UP TO 28.1 WATTS. THESE EVENTS WERE ACCOMPANIED BY LOW SPEED HAZARD, LOW FLOW HAZARD AND MOTOR STOPPED ALARMS. DURING ANALYSIS, THE RETURNED BACKUP SYSTEM CONTROLLER WAS CONNECTED TO THE TEST LABORATORY EQUIPMENT AND HIGH ABNORMAL PUMP PARAMETERS WERE OBSERVED INDICATING A POSSIBLE ISSUE WITH THE DRIVE CIRCUITRY. FURTHER ANALYSIS OF THE RETURNED BACKUP SYSTEM CONTROLLER REVEALED VISIBLE HEAT RELATED DAMAGE TO A COMPONENT OF THE PRIMARY DRIVE CIRCUITRY ON THE MAIN PRINTED CIRCUIT BOARD. THE COMPONENT DAMAGE WITHIN THE DRIVE CIRCUITRY AND THE DATA CONTAINED IN THE LOG FILE INDICATE AN OVERCURRENT CONDITION THAT COULD POTENTIALLY OCCUR DUE TO A PERCUTANEOUS LEAD ISSUE; HOWEVER, A SPECIFIC ROOT CAUSE FOR THE OVERCURRENT CONDITION COULD NOT BE CONCLUSIVELY DETERMINED WITHOUT A FULL EVALUATION OF THE LVAD SYSTEM. THE EVALUATION OF THE RETURNED PRIMARY SYSTEM CONTROLLER CONFIRMED THE REPORTED DAMAGE TO THE BLACK POWER LEAD. DAMAGE TO THE OUTER JACKET INSULATION OF THE BLACK POWER LEAD WAS PRESENT, EXPOSING THE UNDERLYING SHIELDING WIRES. DAMAGE TO THE OUTER JACKET INSULATION OF THE WHITE POWER LEAD WAS ALSO OBSERVED. THE OBSERVED DAMAGE APPEARED TO BE RELATED TO WEAR AND TEAR DURING CLINICAL USE. THE RETURNED PRIMARY SYSTEM CONTROLLER HAD BEEN IN USE FOR ALMOST 4 YEARS. THE OBSERVED DAMAGE TO THE OUTER INSULATION OF THE BLACK AND WHITE POWER LEADS DID NOT AFFECT THE SYSTEM CONTROLLER¿S ABILITY TO OPERATE A TEST PUMP DURING TESTING. THE RETURNED PRIMARY SYSTEM CONTROLLER FUNCTIONED AS INTENDED DURING THE INVESTIGATION EVEN WHILE SUPPORTED INDEPENDENTLY BY EITHER POWER LEADS. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER PUMP STOPPAGE OR LOW SPEED EVENTS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE - 3 YEARS (CALCULATED FROM THE SHIP DATE). THE SYSTEM CONTROLLER WAS RETURNED FOR ANALYSIS. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A ¿LOW SOUNDING¿ ALARM WHILE CONNECTING THE SYSTEM CONTROLLER BLACK POWER LEAD DURING AN EXCHANGE OF POWER SOURCES FROM BATTERIES TO THE POWER MODULE. IT WAS REPORTED THAT THE BLACK POWER LEAD IS FRAYED AND WIRES ARE EXPOSED. THE PATIENT ATTEMPTED TO SWITCH TO THE BACKUP SYSTEM CONTROLLER, WHICH AT THE TIME WAS POWERED BY TWO BATTERIES AND ALARMING; HOWEVER, THE PUMP DID NOT START. WITHIN 30 SECONDS OF THE INTERRUPTION IN PUMP FUNCTION, THE PATIENT SWITCHED BACK TO THE PRIMARY SYSTEM CONTROLLER WHICH STARTED THE PUMP APPROPRIATELY. THE PATIENT WAS REPORTEDLY ASYMPTOMATIC DURING THE EVENT. THE SUBMITTED LOG FILE ANALYZED BY THE MANUFACTURER¿S TECHNICAL SERVICES REPRESENTATIVE CONFIRMED THE REPORTED INTERRUPTION IN PUMP SUPPORT. THE RECORDED EVENTS APPEARED CONSISTENT WITH A POTENTIAL ISSUE WITH THE PERCUTANEOUS LEAD. THE ALARMS APPEARED TO BE OCCURRING ON BOTH POWER MODULE AND ON BATTERIES. THE PATIENT WAS SWITCHED TO A NEW SYSTEM CONTROLLER AND NO FURTHER ALARMS OCCURRED. NO ALARMS OR DRIVELINE FAULT ALARM OCCURRED WHEN THE PATIENT WAS CONNECTED TO THE POWER MODULE VIA A GROUNDED PATIENT CABLE. VISIBLE INSPECTION OF THE PERCUTANEOUS LEAD REVEALED EXTERNAL DAMAGE. AN ADDITIONAL SUBMITTED LOG FILE WAS ANALYZED BY THE MANUFACTURER¿S TECHNICAL SERVICES AND CONTAINED NO UNUSUAL EVENTS. AN ONSITE EVALUATION OF THE PATIENT'S PERCUTANEOUS LEAD WAS PERFORMED AND ALL DIAGNOSTICS WERE NEGATIVE. THE HEALTHCARE PROFESSIONALS MADE A DECISION NOT TO ATTEMPT AN EXTERNAL/DISTAL END REPLACEMENT OF THE PERCUTANEOUS LEAD AS NO COMPROMISED WIRES WERE FOUND. AS OF (B)(6) 2016, THE PATIENT WOULD BE DISCHARGED HOME WITH NEW SYSTEM CONTROLLERS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380563 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR