BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE, INC

    MDR report key: 5273288 · Received December 8, 2015

    Report

    Report Number
    3007042319-2015-03611
    Event Type
    Injury
    Date Received
    December 8, 2015
    Date of Event
    February 20, 2014
    Report Date
    March 11, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED WITH A DRIVELINE INFECTION; TESTING LATER CONFIRMED (B)(6). THE PATIENT'S INFECTION WAS TREATED AND THE ISSUE WAS REPORTEDLY RESOLVED; THE DEVICE WAS NOT RETURNED TO THE AS IT REMAINS IMPLANTED IN THE PATIENT. INFECTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES AND DRIVELINE CARE. WITH REVIEW OF THE AVAILABLE INFORMATION, A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED EVENT CANNOT BE DETERMINED. CLINICAL FACTORS INCLUDING PATIENT'S MEDICAL CONDITION AND COMORBIDITIES MAY HAVE CONTRIBUTED; THERE IS NO INDICATION THAT IT IS RELATED TO ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES. 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. 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

    IT WAS REPORTED FROM THE UNITED STATES ON (B)(6) 2014 THAT DURING A SCHEDULED CLINIC VISIT A MALE PATIENT WAS FOUND TO HAVE WOUND CULTURES (B)(6) FOR (B)(6) OF HIS DRIVELINE EXIT SITE. THE PATIENT HAS A HISTORY OF CHRONIC RECURRENT DRIVELINE INFECTIONS. SIGNS AND SYMPTOMS ON PRESENTATION INCLUDED GENERAL MALAISE AND LOCALIZED DRAINAGE AND PAIN AT THE DRIVELINE EXIT SITE. AN INFECTIOUS DISEASE CONSULTATION ORDERED THE PATIENT TO HAVE A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED AND TO BEGIN A FOUR WEEK COURSE OF INTRAVENOUS CEFAZOLIN. THE PATIENT COULD NOT AFFORD THE PRESCRIBED MEDICATION AND INSTEAD CONTINUED TREATMENT WITH KEFLEX WHICH HE HAD ALREADY BEEN PRESCRIBED AS PROPHYLAXIS TREATMENT FOR HIS PREVIOUS DRIVELINE INFECTION. HE WAS DISCHARGED HOME AFTER THE PICC LINE WAS PLACED. THE LAST REPORT RECEIVED BY THE SITE INDICATED THAT A REPEAT SET OF WOUND CULTURES WERE ALSO (B)(6) FOR (B)(6). THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER AS IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805841 HEARTWARE, INC CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R