BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    MDR report key: 7287398 · Received February 21, 2018

    Report

    Report Number
    3007042319-2018-00737
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 1, 2012
    Report Date
    May 9, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/51 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: CLINICAL EXPERIENCE WITH HEARTWARE LEFT VENTRICULAR ASSIST DEVICE IN PATIENTS WITH END-STAGE HEART FAILURE. ANNALS OF THORACIC SURGERY, 2012; 93: 810-815. DOI:10.1016/J.ATHORACSUR.2011.11.076 THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PUMPS WITH UNKNOWN SERIAL NUMBERS WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED SINCE THE PUMP SERIAL NUMBERS ARE UNKNOWN. REVIEW OF LOG FILES COULD NOT BE PERFORMED SINCE LOG FILES WERE NOT PROVIDED FOR ANALYSIS. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING VENTRICULAR ASSIST DEVICES (VADS) FOR LEFT VENTRICULAR SUPPORT IN ADULTS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. ONE CASE OF MECHANICAL DEVICE FAILURE WAS REPORTED. THE STATUS/LOCATION OF THE VAD IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128444 HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK-PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR