BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 2

    MDR report key: 8499942 · Received April 10, 2019

    Report

    Report Number
    8499942
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 14, 2019
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED VAD COORDINATOR INDICATING THAT HE HAD BEEN HAVING INTERMITTENT RED HEART ALARMS. PT COMPLAINED OF DIAPHORESIS, AND DIZZINESS. DURING CONVERSATION, THE DEVICE ALARMED AGAIN AND THE PATIENT HAD A SYNCOPAL EPISODE. EMS WAS CALLED. UPON ARRIVAL, PATIENT WAS UNRESPONSIVE WITH AGONAL BREATHING. LVAD WAS CHANGED TO BATTERIES FOR TRANSPORT TO CLOSEST ED. HE WAS STABILIZED AND LIFE FLIGHTED OVER TO OUR HOSPITAL. WHEN THE DEVICE WAS CONNECTED TO THE GROUND CABLE TO DOWNLOAD DATA, THE PUMP ALARMED AGAIN. THE PATIENT WAS PLACED BACK ON BATTERIES AND AN UNGROUNDED WITH NO FURTHER ALARMS. WAVEFORMS WERE SENT TO ABBOTT AND THE CONCLUSION WAS A "SHORT TO SHIELD" SITUATION, MEANING THAT THERE IS A COMPROMISED INSULATION TO THE CONDUCTOR(S). OUTSIDE DRIVELINE WAS REPLACED 2 DAYS LATER.

    Description of Event or Problem · 1

    PATIENT CALLED VAD COORDINATOR INDICATING THAT HE HAD BEEN HAVING INTERMITTENT RED HEART ALARMS. PT COMPLAINED OF DIAPHORESIS AND DIZZINESS. DURING CONVERSATION, THE DEVICE ALARMED AGAIN AND THE PATIENT HAD A SYNCOPAL EPISODE. EMS WAS CALLED. UPON ARRIVAL, PATIENT WAS UNRESPONSIVE WITH AGONAL BREATHING. LVAD WAS CHANGED TO BATTERIES FOR TRANSPORT TO CLOSEST ED. HE WAS STABILIZED AND LIFE FLIGHTED OVER TO OUR HOSPITAL. WHEN THE DEVICE WAS CONNECTED TO THE GROUND CABLE TO DOWNLOAD DATA, THE PUMP ALARMED AGAIN. THE PATIENT WAS PLACED BACK ON BATTERIES AND AN UNGROUNDED CABLE WITH NO FURTHER ALARMS. WAVEFORMS WERE SENT TO ABBOTT AND THE CONCLUSION WAS A "SHORT TO SHIELD" SITUATION, MEANING THAT THERE IS A COMPROMISED INSULATION TO THE CONDUCTOR(S). OUTSIDE DRIVELINE WAS REPLACED 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294086 HEARTMATE 2 VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORP. 106015

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA