BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 8611949 · Received May 14, 2019

    Report

    Report Number
    MW5086631
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    February 2, 2019
    Report Date
    May 10, 2019
    Manufacturer
    ST JUDE/ ABBOTT LABORATORIES
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEARTMATE II LVAD PATIENT PRESENTED TO EMERGENCY ROOM (B)(6) 2019 WITH LOW FLOW ALARMS ON CONTROLLER. UPON DEVICE INTERROGATION, PATIENT NOTED TO HAVE MULTIPLE PUMP STOPS. PATIENT HEMODYNAMICALLY STABLE AND ADMITTED TO HOSPITAL FOR OBSERVATION AND FURTHER WORK-UP. ABBOTT ENGINEERS AT HOSPITAL (B)(4) 2019 TO ATTEMPT EXTERNAL DRIVELINE REPAIR, HOWEVER PATIENT MADE DECISION NOT TO PURSUE LINE REPLACEMENT AS HIGH LIKELIHOOD THE REPAIR WOULD NOT FIX THE PUMP STOPS (FRACTURE FELT TO BE ON THE INSIDE OF BODY, NO FOCAL AREA OF DAMAGE ABLE TO BE PIN-POINTED ON X-RAY). PATIENT DISCHARGED FROM HOSPITAL SHORTLY AFTER, WITH PUMP STOPS STILL OCCURING. ON (B)(6) 2019 22:00- PATIENT RETURNED TO EMERGENCY DEPARTMENT VIA AMBULANCE WITH LOW FLOW ALARMS ON CONTROLLER, SAME ISSUE AS HAPPENING ABOVE - PATIENT IS HAVING PUMP STOPS RELATED TO A PHASE TO PHASE SHORT WITHIN HER DRIVELINE. AREA OF FRACTURE (INTERNAL/EXTERNAL) UNKNOWN. HEARTMATE II PUMP STOPPED SOMETIME BETWEEN 21:30-22:30 AND DID NOT RESTART. PATIENT WAS CARED FOR AND MONITORED IN CICU, REMAINED STABLE WITH LIFE SUPPORT DEVICE OFF. 2/3 AM PUMP HAS BEEN STOPPED FOR MORE THAN 8 PLUS HOURS, CONTROLLER REMOVED FROM DRIVELINE SO PUMP IS UNABLE TO ACCIDENTALLY RESTART. PATIENT OBSERVED IN HOSPITAL FOR A FEW MORE DAYS AND THEN SENT HOME ON PALLIATIVE CARE AND INOTROPE SUPPORT FOR SYMPTOM MANAGEMENT OF END STAGE HEART FAILURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403504 HEARTMATE II LVAD VENTRICULAR (ASSIST) BYPASS DSQ ST JUDE/ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| L