BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2881506 · Received December 18, 2012

    Report

    Report Number
    2916596-2012-01221
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 19, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE THE PATIENT WAS AMBULATING IN THE HALLS, THE PUMP STOPPED AND THE PATIENT STATED THAT SHE WAS FEELING DIZZY. THE HISTORY SCREEN ON THE SYSTEM MONITOR DISPLAYED A PUMP STOP ALARM AND RESTART. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE PATIENT WAS ADMINISTERED ANTICOAGULATION MEDICATION. THE PATIENT'S INR WAS THERAPEUTIC AND HEMOLYSIS LABS WERE NEGATIVE. WAVEFORMS WERE SENT IN FOR EVALUATION AND IT APPEARED THAT IT MAY HAVE BEEN A SUCTION EVENT. THE HOSPITAL STAFF DECREASED THE PUMP SPEED TO 8800 RPMS AND NO ALARMS/PI EVENTS OCCURRED AFTER THAT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. WAVEFORMS WERE REVIEWED AGAIN A WEEK LATER AND THE PATIENT WAS SEEN IN THE CLINIC AND NOTHING WAS FOUND. IT WAS REPORTED THAT THE HOSPITAL STAFF DOES NOT FEEL THAT CHANGING THE SYSTEM CONTROLLER HAD ANYTHING TO DO WITH RESOLVING THE ISSUE, BUT CHANGING THE SPEED DID. IT WAS REPORTED THAT THE PATIENT WAS READMITTED WITH FLUID OVERLOAD AND DISCHARGED 3 DAYS LATER AND "IS GETTING ALONG OK." THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118910

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention