BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3810862 · Received March 26, 2014

    Report

    Report Number
    2916596-2014-00307
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 22, 2014
    Report Date
    February 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE HOSPITAL REPORTED A LOW FLOW ALARM. THE LOW FLOW HAZARD EVENT WAS CONFIRMED IN THE LOG FILE. IT APPEARED TO BE ASSOCIATED WITH A LOSS OF POWER. ONCE POWER RETURNED, THE PUMP BEGAN TO OPERATE NORMALLY. NO FURTHER ALARMS WERE REPORTED. THE ALARMS HAVE NOT RE-OCCURRED SINCE (B)(6) 2014 PER THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176549 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122808

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention