BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5922574 · Received September 1, 2016

    Report

    Report Number
    3007042319-2016-03125
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 10, 2016
    Report Date
    August 10, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT DUE TO THE FACT THAT THE ISSUE OCCURRED AT THE BEGINNING OF THE PUMP START (CLAMPED, BEFORE DE-AIRING) AND THE PROCEDURE WAS STILL ONGOING, NO DELAY WAS CAUSED AND NO ADVERSE PATIENT EFFECT WAS CAUSED. PATIENT WAS EXTUBATED THE DAY AFTER IMPLANT AND SINCE 08/15/2016, THE PATIENT IS DOING FINE. THE DRIVELINE EXTENSION CABLE WITH LOT #1163235 WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE LOG FILES WHICH REVEALED ELECTRICAL FAULT ALARMS ON THE REPORTED EVENT DATE AUGUST 10, 2016. VISUAL INSPECTION OF THE DRIVELINE EXTENSION CABLE DID NOT REVEAL ANY ANOMALIES. FUNCTIONAL TESTING DEMONSTRATED THAT THE LOCKING MECHANISM WORKED AN INTENDED. ADDITIONALLY, AN ATTEMPT WAS MADE TO REPLICATE THE REPORTED EVENT BY CONDUCTING A PRE-IMPLANT TEST PER THE INSTRUCTIONS FOR USE (IFU) WITH REPRESENTATIVE SAMPLES HW27124, DRIVELINE EXTENSION CABLE WITH LOT #1163235, CON005269 AND BAT217837. THE REPORTED "ELECTRICAL FAULT ALARM" EVENT COULD NOT BE REPLICATED AS THE SYSTEM PERFORMED AS INTENDED AND THE PUMP WAS ABLE TO START WITHOUT ANY ISSUES. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE OF ANY DEVICE MALFUNCTION THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO IMPROPER CONNECTION BETWEEN THE DRIVELINE EXTENSION CABLE AND THE 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

    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. AN AUDIBLE CLICK SHOULD BE HEARD WHEN CONNECTING THE DRIVELINE TO THE CONTROLLER OR DRIVELINE EXTENSION. FAILURE TO ENSURE A SECURE CONNECTION MAY CAUSE AN ELECTRICAL FAULT. DRIVELINE EXTENSION CABLE - USED ONLY DURING THE PRE-IMPLANT WET TEST TO KEEP THE NON-STERILE CONTROLLER ISOLATED FROM THE STERILE FIELD. THE DRIVELINE EXTENSION CABLE IS NOT INTENDED TO BE USED AFTER THE PUMP IS IMPLANTED IN THE PATIENT. THE DRIVELINE EXTENSION CABLE SHOULD ONLY BE USED DURING THE PRE-IMPLANT TEST. IT SHOULD NOT BE CONNECTED WHEN THE VAD IS RUNNING. WEARING CLEAN, DRY, GLOVES, DISCONNECT THE DRIVELINE EXTENSION CABLE FROM THE CONTROLLER AND THE PUMP. 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 THE IMPLANT, AFTER THE PUMP WAS PLACED IN SITU AND READY TO BE STARTED, THE DRIVELINE EXTENSION WAS CONNECTED TO THE CONTROLLER, BUT BEFORE STARTING THE PUMP, AN E-FAULT OCCURRED. THE WET TEST WAS PERFORMED WITH THE SAME CABLE AND PASSED WITH NO PROBLEMS OR ALARMS. AFTER CONNECTING THE EXTENSION CABLE TO THE SECOND CONTROLLER ANOTHER E-FAULT ALARM OCCURRED BEFORE STARTING THE PUMP. ALL CONNECTIONS HAVE BEEN CHECKED WITHOUT SUCCESS. A NEW EXTENSION CABLE WAS USED AND WORKED WITH NO ISSUES. NO CONSEQUENCE TO PATIENT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574260 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1