BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4125947 · Received September 29, 2014

    Report

    Report Number
    3007042319-2014-01007
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED IN THE FIELD BY HEARTWARE CLINICAL ENGINEERING PERSONNEL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE SITE PERFORMED A CLEANING PROCEDURE TO REMOVE THE CONTAMINATION FROM THE DRIVELINE CONNECTOR. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. PICTURES SENT BY THE FIELD SERVICE ENGINEER CONFIRM THE PRESENCE OF A FOREIGN MATERIAL IN THE DRIVELINE CONNECTOR PORT OF THE CONTROLLER. THE REPORTED ELECTRICAL FAULTS WERE CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE ELECTRICAL FAULT ALARMS ON THE DATE OF THE REPORTED EVENT. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH ELECTRICAL FAULTS ARE MANY TIMES ATTRIBUTED TO FOREIGN MATERIAL CONTAMINATION ON THE DRIVELINE CONNECTOR RESULTING IN A PARTIAL LOSS OF ELECTRICAL CONTINUITY. THE MOST LIKELY ROOT CAUSE OF THE REPORTED ELECTRICAL FAULT EVENT IS FOREIGN MATERIAL CONTAMINATION WITHIN THE DRIVELINE CONNECTOR. CLINICAL PROCESSES AND SUBSEQUENT HANDLING OF THE DRIVELINE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THE INSTRUCTIONS FOR USE (IFU) NOTE SPECIFICALLY STATES TO PROTECT THE DRIVELINE CONNECTOR OR IMPROPER USE OF THE DRIVELINE CAP COULD RESULT IN CONTAMINATION OR DAMAGE TO THE CONNECTOR AND ELECTRICAL FAULT ALARMS COULD OCCUR. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE SITE PERFORMED A CLEANING PROCEDURE TO REMOVE THE CONTAMINATION FROM THE DRIVELINE CONNECTOR. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. PICTURES SENT BY THE FIELD SERVICE ENGINEER CONFIRM THE PRESENCE OF A FOREIGN MATERIAL IN THE DRIVELINE CONNECTOR PORT OF THE CONTROLLER. THE REPORTED ELECTRICAL FAULTS WERE CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE ELECTRICAL FAULT ALARMS ON THE DATE OF THE REPORTED EVENT. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH ELECTRICAL FAULTS ARE MANY TIMES ATTRIBUTED TO FOREIGN MATERIAL CONTAMINATION ON THE DRIVELINE CONNECTOR RESULTING IN A PARTIAL LOSS OF ELECTRICAL CONTINUITY. THE MOST LIKELY ROOT CAUSE OF THE REPORTED ELECTRICAL FAULT EVENT IS FOREIGN MATERIAL CONTAMINATION WITHIN THE DRIVELINE CONNECTOR. CLINICAL PROCESSES AND SUBSEQUENT HANDLING OF THE DRIVELINE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THE INSTRUCTIONS FOR USE (IFU) NOTE SPECIFICALLY STATES TO PROTECT THE DRIVELINE CONNECTOR OR IMPROPER USE OF THE DRIVELINE CAP COULD RESULT IN CONTAMINATION OR DAMAGE TO THE CONNECTOR AND ELECTRICAL FAULT ALARMS COULD OCCUR. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Description of Event or Problem · 1

    APPROXIMATELY THREE WEEKS POST HEARTWARE LVAD IMPLANTATION, THE PATIENT PERFORMED AN ELECTIVE CONTROLLER EXCHANGE AFTER EXPERIENCING ELECTRICAL FAULTS ALARMS. VISUAL INSPECTION REVEALED CONTAMINATION WITHIN THE DRIVELINE CONNECTOR AND THE CONTROLLER'S CONNECTOR. THE HEARTWARE FIELD ENGINEER PERFORMED A CLEANING PROCEDURE AND A SECOND CONTROLLER EXCHANGE. THE EXCHANGED CONTROLLERS WILL BE RETURNED TO HEARTWARE FOR ANALYSIS AND A NEW BACKUP CONTROLLER WAS ISSUED TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605022 HEARTWARE® VENTRICULAR ASSIST SYSTEM HEARTWARE® VENTRICULAR ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROLLER- CON185812| CONTROLLER- CON183899