BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 6827620 · Received August 29, 2017

    Report

    Report Number
    3007042319-2017-02922
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    July 31, 2017
    Report Date
    August 2, 2017
    Manufacturer
    HEARTWARE
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    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 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. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (ADDITIONAL INFORMATION RECEIVED). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE "HIGH WATT" ALARMS RESOLVED. THE PATIENT DID NOT RECEIVE ANY FURTHER INTERVENTION DURING HOSPITAL COURSE. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2017. OF NOTE, THE PATIENT WAS THERAPEUTIC ON ANTICOAGULATION AT THE TIME OF ADMISSION. THE PATIENT DID NOT HAVE A RECENT ILLNESS THAT MAY HAVE PRECIPITATED PUMP THROMBUS. THE DEVICE WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED AN INCREASE IN POWER CONSUMPTION STARTING (B)(6) 2017; 81 HIGH WATT ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2017. OF NOTE, IT WAS REPORTED THAT THE PATIENT RECEIVED HEPARIN TREATMENT AFTER WHICH THE POWER AND FLOW WENT BACK TO NORMAL. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. 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, ISSUES 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PRESENTED WITH "HIGH WATT" ALARMS. THE PATIENT DID NOT EXHIBIT ANY SIGNS OR SYMPTOMS AT THE TIME OF PRESENTATION. THE MEDICAL TEAM SUSPECTED THROMBUS INSIDE THE PUMP. CONTROLLER LOG FILES WERE SENT. PRELIMINARY LOG FILE ANALYSIS REVEALED 112 "HIGH WATT" ALARMS LOGGED SINCE (B)(6) 2017. THE PATIENT WAS ADMINISTERED HEPARIN. IT WAS LAST REPORTED THAT THE PATIENT IS STABLE BUT REMAINS HOSPITALIZED. OF NOTE, THE PATIENT WAS ON ANTICOAGULATION MEDICATION AT THE TIME OF THE REPORTED EVENT. THE PATIENT'S HEMATOCRIT SETTING ON THE CONTROLLER WAS REPORTEDLY CORRECT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609230 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R