BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM LIFE PROTEK LVAD

    MDR report key: 8202768 · Received December 27, 2018

    Report

    Report Number
    MW5082649
    Event Type
    Injury
    Date Received
    December 27, 2018
    Date of Event
    December 17, 2018
    Report Date
    December 26, 2018
    Manufacturer
    TANDEM LIFE / LIVANOVA USA, INC. / CARDIAC ASSIST INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PER INCIDENT REPORT: PT WITH TEMPORARY TANDEM HEART PROTEK LEFT VENTRICULAR ASSIST DEVICE PLACED (B)(6) 2018. PT¿S TANDEM HEART CONSOLE BEGAN ALARMING ¿INFUSATE PRESS ERROR¿, NURSES ASSESSED THE INFUSATE TUBING AND OBSERVED A KINK IN THE TUBING NEAR THE CONSOLE. THE TUBING WAS TAKEN OUT OF THE CONSOLE AND UNKINKED. CONSOLE THEN BEGAN ALARMING ¿LOW FLOW¿ AND SECONDARY MOTOR CONTROL UNIT WAS INITIATED WITH SCREEN SHOWING ¿FLOW: 0.7 LPM AND RPM: 6700¿. PRIMARY NURSE ALERTED CHARGE NURSE AND RESIDENT. CHARGE NURSE CAME TO BEDSIDE AND ATTEMPTED TO RESTART PUMP. TANDEM HEART SCREEN SHOWED ¿SWITCHOVER¿ ALERT DISPLAYING ¿ATTENTION CONTROLLER HAS SWITCHED TO BACK UP, ENSURE PUMP IS CONNECTED TO THE CONTROLLER AND PUMP LOWER HOUSING IS DE-AIRED AND FILLED WITH SALINE¿. CHARGE NURSE THEN CHECKED LINES AND CONNECTIONS, WHERE BLOOD WAS BACKED UP IN THE INFUSATE LINE TUBING NEAR THE CONSOLE AND PUMP WAS OVERHEATED TO TOUCH. NO CLOT WAS FOUND IN THE PUMP OR TUBING. CARDIOTHORACIC SURGERY FELLOW, PERFUSIONIST AND TANDEM HEART REP WERE CALLED. PT HAD STABLE VITAL SIGNS DURING LOW FLOWS AND WAS LAYING FLAT IN CASE OF AIR ENTERING THE SYSTEM. CONSOLE WAS CHARGED TO BACK UP AND ALARMS CONTINUED. PERFUSIONIST INSTRUCTED CHARGE NURSE TO NOT CLAMP THE CANNULAS AND CONTINUE FLOWS UNTIL SUPPORT STAFF ARRIVED. CT SURGERY FELLOW AT BEDSIDE INSTRUCTED NURSE TO PREPARE FOR PUMP EXCHANGE FROM TANDEM HEART TO CENTRIMAG. TEE DONE WITH ANESTHESIA ATTENDING AND PUMP EXCHANGED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040353 TANDEM LIFE PROTEK LVAD PVAD, CATHETER, CANNULA AND TUBING, VASCULAR CARDIOPULMONARY BYPASS DWF TANDEM LIFE / LIVANOVA USA, INC. / CARDIAC ASSIST INC. 00140398 TANDEM PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention