BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6037611 · Received October 18, 2016

    Report

    Report Number
    3007042319-2016-03679
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    June 20, 2016
    Report Date
    September 27, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 HVAD CONTROLLER IS A MICROPROCESSOR UNIT THAT CONTROLS AND MANAGES THE SYSTEM. IT SENDS POWER AND OPERATING SIGNALS TO THE BLOOD PUMP AND COLLECTS INFORMATION FROM THE PUMP. THE HVAD CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL EXPLAIN THE CORRECT METHOD OF CONNECTING TO AND DISCONNECTING FROM THE POWER SOURCES AND THE CONTROLLER TO PREVENT DAMAGE TO EITHER THE POWER SOURCE CONNECTIONS OR THE CONTROLLER POWER PORTS. ACCORDING TO THE IFU AND PATIENT MANUAL, USERS ARE INSTRUCTED TO RETURN ANY DAMAGED COMPONENTS TO HEARTWARE. IN ADDITION, THE USER IS CAUTIONED TO ALWAYS HAVE A BACKUP CONTROLLER AVAILABLE AND PROGRAMMED IDENTICALLY TO THE PRIMARY CONTROLLER. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. 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 INDICATES THAT THE SITE IS NOT ABLE TO IDENTIFY WHICH BATTERIES WERE ASSOCIATED WITH THIS EVENT. THEY FURTHER REPORTED THAT THE EXCHANGE OF THE CONTROLLER RESOLVED THE ISSUE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS. THE CONTROLLER ((B)(4)) 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. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. AN ATTEMPT WAS MADE TO REPLICATE THE ISSUE BY MANIPULATING THE BATTERY'S CONNECTION TO THE CONTROLLER DURING THE ANALYSIS OF THE UNIT. RESULTS REVEALED THAT THE ELECTRICAL CONNECTION BETWEEN THE BATTERY AND CONTROLLER WAS STABLE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED THE SMR SOFTWARE. THE SOFTWARE UPGRADE CONTAINS A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH FIFTEEN (15) MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BATTERIES ((B)(4)). THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. 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 AN UPDATED CONTROLLER WAS ASSOCIATED WITH BATTERY SWITCHING WHEN THE BATTERIES HAD MORE THAN 25% CAPACITY.ࠔHE SITE REPORTED THAT THE EVENT COULD NOT BE REPRODUCED BY MANIPULATING THE CONNECTIONS.ࠔHE CONTROLLER WAS EXCHANGED AT THE HOSPITAL WITH NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688192 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR