BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4923326 · Received July 17, 2015

    Report

    Report Number
    3007042319-2015-01504
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOG FILE ANALYSIS REVIEW DATE: (B)(6) 2015. DATA THROUGH: (B)(6) 2015. NORMAL POWER CONSUMPTION. -7 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2015. THE CURRENT LOW FLOW ALARM LIMIT IS SET TO 3.0 LPM. -1 VAD DISCONNECT ALARM WAS LOGGED ON (B)(4) ON (B)(6) 2015. -20 ELECTRICAL FAULT ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2015. -1 CONTROLLER FAULT ALARM WAS LOGGED ON (B)(4) ON (B)(6) 2015. 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. TO PREVENT DRIVELINE CONNECTOR CONTAMINATION, UTILIZE THE DRIVELINE CAP, FOLLOW THE TUNNELING TECHNIQUE AS OUTLINED IN THE IFU, KEEP THE CONNECTIONS CLEAN AND FREE OF ANY FOREIGN MATERIAL AND EXAMINE THE DRIVELINE CONNECTION PRIOR TO CONNECTING IT TO THE CONTROLLER. THE DRIVELINE CONNECTOR MUST BE COMPLETELY CLEAN AND DRY WHEN CONNECTED TO THE CONTROLLER. FOREIGN SUBSTANCES, SUCH AS LUBRICANTS, BLOOD OR SALINE SHOULD NOT BE PRESENT ON THE DRIVELINE CONNECTOR WHEN YOU CONNECT IT TO THE CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS TWO OF TWO REPORTS (3007042319-2015-01503) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. CURRENT DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULTS OF THE INTERNAL INVESTIGATION AND PER MANAGEMENT DIRECTIVE, NO ADDITIONAL INVESTIGATION OF THIS EVENT IS REQUIRED AT THIS TIME. THE MANUFACTURER ALSO IDENTIFIED THE ISSUE TO BE A DESIGN DEFICIENCY THEREFORE NO DEVICE HISTORY RECORD IS REQUIRED FOR THIS EVENT. THE MOST LIKELY CAUSE OF THE ELECTRICAL FAULT ALARMS ARE RELATED TO CONTAMINATION OF THE DRIVELINE CONNECTOR IN THAT THE DRIVELINE CAP AND DRIVELINE CONNECTION ALLOW EXTERNAL CONTAMINATES TO ENTER THE DRIVELINE CONNECTOR PINS WHICH MAY LEAD TO ELECTRICAL FAULTS. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO REPORTS (3007042319-2015-01503 AND 3007042319-2015-01504) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MEDICAL STAFF THAT AN INPATIENT EXPERIENCED ELECTRICAL FAULT ALARMS. A VISUAL ASSESSMENT OF THE DRIVELING WAS PERFORMED BY THE FACILITY STAFF AND THERE IS NO REPORT OF CRACKS OR CONDENSATION. CLINICAL ENGINEERING CONDUCTED A DRIVELINE CLEANING AT THE FACILITY. THE SERVICE REPORT IS DATED JULY 3, 2015 AND CONTAINS THE FOLLOWING INFORMATION: THE FIRST ALARM WAS REPORTED AS (B)(6) 2015. SERVICE EVALUATION: WHITE RESIDUE ON THE BLACK WIRE AND RED MATERIAL ON THE CONNECTOR BODY. THE PATIENT WAS PREPARED FOR THE PROCEDURE WITH VARIOUS IV MEDICATIONS. THE PUMP STOP TIME DURING THE PROCEDURE IS ESTIMATED AT APPROXIMATELY 40 SECONDS. VERIFICATION OF THE REPAIR ACTION IS NOTED TO SOLVE THE EVENT. THE PINS WERE CLEANED UNTIL "NO RESIDUE WAS EVIDENT. THE PATIENT WAS REPORTED TO BE STABLE DURING THE PROCEDURE PER THE PHYSICIAN. NO ADDITIONAL INFORMATION WAS REPORTED. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465367 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1