BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4250578 · Received November 14, 2014

    Report

    Report Number
    3007042319-2014-01221
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 3, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. CONTROLLER (B)(4) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THE CONTROLLER FAILED VISUAL INSPECTION AS A RESULT OF A BENT PIN ON THE POWER SOURCE ONE (1) CONNECTOR; THUS CONFIRMING THE REPORTED EVENT. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE PUMP REMAINS IMPLANTED AND THAT CONTROLLER IS GOING TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    DHR REVIEW RESULTS: A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT EXPECTED TO REVEAL RELEVANT INFORMATION, AS PER THE LOGS, THIS CONTROLLER WAS IN USE FOR OVER THREE YEARS PRIOR TO THE REPORTED DAMAGED PINS. SERVICING HISTORY REVIEW RESULTS: A REVIEW OF THE COMPLAINT DATA WAS COMPLETED FOR THIS PATIENT. THERE WERE NO PREVIOUS COMPLAINTS FOR THIS PATIENT. THERE IS NO RECORD OF PREVIOUS SERVICING FOR THIS PATIENT. DEVICE TESTING RESULTS SUMMARY: THE CONTROLLER FAILS VISUAL AND FUNCTIONAL TESTING AS A RESULT OF A BENT PIN ON THE PS1 CONNECTOR. THE DAMAGED PORT WAS UNABLE TO TRANSFER ELECTRICAL SIGNAL FROM THE BATTERY OR AC POWER SOURCE TO THE CONTROLLER RENDERING IT INEFFECTIVE. THIS FAILURE IS MOST LIKELY DUE TO A FORCED OR IMPROPER CONNECTION TO THE PORT CAUSING THE PIN TO BREAK. LABELING AND RISK MANAGEMENT REVIEW RESULTS: AS PER IFU LABELING (PATIENT MANUAL): CAUTION: CONFIRM THAT THE POWER CABLES ARE PROPERLY LOCKED TO THE CONTROLLER BY GENTLY PULLING THE CABLE NEAR THE CONNECTOR. WHEN CONNECTING CABLES, DO NOT FORCE CONNECTORS TOGETHER WITHOUT PROPER ALIGNMENT. FORCING TOGETHER MISALIGNED CONNECTORS MAY DAMAGE THE CONNECTORS. ALL CONNECTORS SHOULD BE HANDLED WITH CARE AND KEPT FREE OF LIQUID, DUST AND DIRT. DO NOT KINK THE POWER CABLES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PERFUSIONIST THAT APPROXIMATELY THREE YEARS AND SIX MONTHS AFTER IMPLANTATION OF AN LVAD, THE PINS ARE BENT ON PORT TWO OF THE CONTROLLER. A CONTROLLER EXCHANGED WAS PERFORMED AND THE "PATIENT IS DOING FINE" AFTER CONTROLLER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737398 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)_CONTROLLER