BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6043496 · Received October 20, 2016

    Report

    Report Number
    3007042319-2016-03711
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 27, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    FSCA APRIL2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATES THAT POWER PORT 1 OF THE PATIENT'S CONTROLLER WAS LOOSE. THE USER DID NOT USE EXCESSIVE FORCE WHEN TRYING TO CONNECT TO THE CONTROLLER. THE DEVICE HAD NOT BEEN DROPPED AND THE EVENT WAS NOT ASSOCIATED WITH ANY CONTROLLER ALARMS OR VAD STOPS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    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. THE HVAD CONTROLLER IS A MICROPROCESSOR UNIT THAT CONTROLS AND MANAGES THE SYSTEM. IT SENDS POWER AND OPERATING SIGNALS TO THE BLOOD PUMP AND COLLECTS INFORMATION FROM THE PUMP. THE HVAD CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL EXPLAIN THE CORRECT METHOD OF CONNECTING TO AND DISCONNECTING FROM THE POWER SOURCES AND THE CONTROLLER TO PREVENT DAMAGE TO EITHER THE POWER SOURCE CONNECTIONS OR THE CONTROLLER POWER PORTS. ACCORDING TO THE IFU AND PATIENT MANUAL, USERS ARE INSTRUCTED TO RETURN ANY DAMAGED COMPONENTS TO HEARTWARE. IF THE CONTROLLER IS ONLY CONNECTED TO ONE POWER SOURCE, THE CONTROLLER WILL FUNCTION, BUT WILL SOUND AN ALARM AFTER TWENTY SECONDS. IN ADDITION, THE USER IS CAUTIONED TO ALWAYS HAVE A BACKUP CONTROLLER AVAILABLE AND PROGRAMMED IDENTICALLY TO THE PRIMARY CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A POWER PORT OF THE CONTROLLER WAS LOOSE. THE CONTROLLER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED DURING VISUAL INSPECTION. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING BUT FAILED VISUAL INSPECTION DUE TO A LOOSE POWER PORT 1 CONNECTOR. A POSSIBLE ROOT CAUSE OF THE LOOSE CONNECTOR MAY BE ATTRIBUTED TO A SHIFT IN THE MANUFACTURING PROCESS. THE MANUFACTURER HAS OPENED AN INVESTIGATION TO EVALUATE THE LOOSE CONNECTORS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE POWER PORT OF A PATIENT'S CONTROLLER WAS LOOSE. THE DEVICE WAS EXCHANGED WITH NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696435 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1