BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 7476829 · Received May 1, 2018

    Report

    Report Number
    3007042319-2018-01694
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    March 30, 2018
    Report Date
    October 25, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. REVIEW OF THE CONTROLLER LOG FILES REVEALED A SHARP DECREASE IN POWER CONSUMPTION ON (B)(6) 2018. 98 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2018. AS A RESULT, THE REPORTED HIGH POWER EVENT COULD NOT BE CONFIRMED. POST-EXPLANT FUNCTIONAL ANALYSIS ON THE RETURNED PUMP WAS NOT POSSIBLE SINCE THE DRIVELINE WAS TOO SHORT TO BE ABLE TO SPLICE THE DRIVELINE AND THEN CONDUCT FUNCTIONAL TESTING. DIMENSIONAL VERIFICATION DID NOT IDENTIFY ANY DISCREPANCIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. VISUAL EXAMINATION REVEALED NO ABRASIONS ON THE UPPER/LOWER HOUSING CERAMIC SURFACES OR ON THE SUPERIOR/INFERIOR SURFACES OF THE IMPELLER. PATHOLOGY REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE PUMP. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR POOR VAD FILLING. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, I SSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    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 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH POWER ON THE VENTRICULAR ASSIST DEVICE (VAD) AND THROMBUS WAS SUSPECTED. THE PATIENT¿S LACTATE DEHYDROGENASE (LDH) WAS ELEVATED. THE PUMP WAS EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319670 HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| L| R