BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4073020 · Received September 9, 2014

    Report

    Report Number
    3007042319-2014-00935
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED IN THE FIELD BY HEARTWARE CLINICAL ENGINEERING PERSONNEL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE SITE PERFORMED A CLEANING PROCEDURE TO REMOVE THE CONTAMINATION FROM THE DRIVELINE CONNECTOR. THE ORIGINAL CONTROLLER REMAINED IN USE AFTER CLEANING PROCEDURE. DEVICES WERE NOT RETURNED AND THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH ELECTRICAL FAULTS ARE MANY TIMES ATTRIBUTED TO A FOREIGN MATERIAL CONTAMINATION ON THE DRIVELINE CONNECTOR RESULTING IN A PARTIAL LOSS OF ELECTRICAL CONTINUITY. THE MOST LIKELY ROOT CAUSE OF THE REPORTED ELECTRICAL FAULT EVENT IS AN INGRESS OF CONTAMINATES ONTO THE DRIVELINE CONNECTOR PINS. THE CLINICAL PROCESS AND SUBSEQUENT HANDLING OF THE DRIVELINE MAY HAVE ALLOWED EXTERNAL CONTAMINATES TO ENTER THE DRIVELINE CONNECTOR. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. INFORMATION FOR USE (IFU) STATES ABOUT ELECTRICAL FAULTS -A FAULT IN THE CONTINUITY OF THE PUMP TO CONTROLLER ELECTRICAL CONNECTION TRIGGERS THIS ALARM. THE FAULT COULD BE IN THE SYSTEM MOTOR, DRIVELINE AND CONNECTOR OR WITHIN THE CONTROLLER. THE AUDIO PORTION OF THIS ALARM CAN BE PERMANENTLY DISABLED VIA THE MONITOR. WHEN THIS ALARM CONDITION OCCURS, THE SYSTEM PUMP WILL BE RUNNING ON A SINGLE STATOR AND WILL CONSUME SLIGHTLY MORE POWER. THE IFU ALSO PROVIDES INSTRUCTIONS AND SURGICAL TECHNIQUE TO AVOID CONTAMINATION OF THE DRIVELINE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS AFTER IMPLANT THIS PATIENT EXPERIENCED ELECTRICAL FAULTS ALARMS. INSPECTION OF THE DRIVELINE CONNECTOR BY THE HEARTWARE FIELD SERVICE ENGINEER CONFIRMED CONTAMINATION. A CLEANING PROCEDURE WAS PERFORMED WITH CONTROLLER EXCHANGE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553331 HEARTWARE® VENTRICULAR ASSIST SYSTEM HEARTWARE® VENTRICULAR ASSIST SYSTEM, DRIVELINE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROLLER - (B)(4)