BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6387217 · Received March 8, 2017

    Report

    Report Number
    3007042319-2017-00625
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 8, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    UDI-DI
    00888707000116
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-0005-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE REPORTED EVENT OF A LOOSE POWER PORT ASSEMBLY WAS CONFIRMED ON THE RETURNED CONTROLLER, (B)(4). 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. ANALYSIS OF THE DEVICE REVEALED THAT DEVICE FAILED VISUAL INSPECTION DUE TO A LOOSE POWER PORT 1 (PS1) CONNECTOR WITH A MISSING O-RING GASKET. FURTHER ANALYSIS REVEALED THAT THE POWER PORT LOCKNUT WAS FOUND LOOSE INTERNALLY. A POSSIBLE ROOT CAUSE OF THE LOOSE CONNECTOR MAY BE ATTRIBUTED TO A SHIFT IN THE MANUFACTURING PROCESS. THE MANUFACTURER HAS AN OPEN INTERNAL INVESTIGATION TO EVALUATE THE ANOMALIES OF 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

    IT WAS REPORTED FROM THE MCS COORDINATOR THAT THE PATIENT'S CONTROLLER NEEDS TO BE RETURNED. A WASHER CAME OFF OF PORT #1 WHICH HAS CAUSED THE PORT TO BECOME LOOSE. THE USER DID NOT USE EXCESSIVE FORCE WHEN TRYING TO CONNECT, THE CONTROLLER WAS NOT DROPPED AND EVENT WAS NOT ASSOCIATED WITH ANY ALARMS OR PUMP STOPS. THE CONTROLLER WAS EXCHANGED WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171196 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE:, DSQ HEARTWARE, INC 00888707000116

    Patients

    Seq Age Sex Outcome Treatment
    1