BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5720555 · Received June 13, 2016

    Report

    Report Number
    3007042319-2016-02177
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 23, 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
    BN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS RETURNED FOR EVALUATION. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE DEVICE FAILED VISUAL INSPECTION DUE TO A DISPLACED GASKET ON PORT 1 AND PORT 1 BEING LOOSE. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. HOWEVER, IT WAS NOTED THAT THERE WAS A REWORK PERFORMED FOR THE SERIAL PORT GASKET BUT THIS HAS NO BEARING ON THE REPORTED LOOSE CONNECTOR. THE MOST LIKELY ROOT CAUSE OF THIS FAILURE IS A SHIFT IN THE MANUFACTURING PROCESS. LOOSE PORT AND DISPLACED GASKET ANOMALIES ARE BEING INVESTIGATED BY THE MANUFACTURER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER 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 INSTRUCTIONS FOR USE AND PATIENT MANUAL INCLUDE A WARNING TO KEEP A SPARE BACK UP CONTROLLER AVAILABLE AT ALL TIMES AND OUTLINES THAT IF THERE IS A CONTROLLER FAILURE, THE CONTROLLER SHOULD BE SWITCHED TO THE BACK-UP CONTROLLER. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. 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 THAT DURING SMR-UPGRADE PRELIMINARY TEST PROCEDURE, THE CONTROLLER FAILED STEP 1.1 DUE TO THE POWER CONNECTOR (PORT 1) COMING LOOSE AT THE CONTROLLER BY SLIPPING OUT OF THE SEALING RING (BETWEEN CONNECTOR AND HOUSING). THE CONTROLLER WAS REPLACED. THE PATIENT TOLERATED THE EXCHANGE WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376195 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1