BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4121261 · Received September 22, 2014

    Report

    Report Number
    2916596-2014-01670
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT WAS ADMITTED INTO THE HOSP ON (B)(6) 2014 FOR INTERMITTENT LOW FLOW ALARMS THAT HAD OCCURRED, AND THE LONGEST ALARM WAS APPROXIMATELY 30 SECONDS. THE PT WAS GIVEN 500CC OF FLUID AND HIS SPEED WAS INCREASED FROM 8200 RPM TO 8600 RPM. HIS BLOOD PRESSURES WERE 90S/50S. THE HOSP STAFF INITIALLY THOUGHT THE PT WAS POSSIBLY DEHYDRATED SINCE HE WAS ON LASIX 20MG/DAY AND IS VERY CAUTIOUS ABOUT HIS FLUID INTAKE (48OZ/DAY). THE PT'S LDH INCREASED FROM 293 TO 704. THE FOLLOWING DAY THE NURSE REPORTED THAT LOW FLOW ALARMS WERE CONTINUOUSLY OCCURRING (LONGEST APPROXIMATELY 3 MIN 30 SEC). THE PT WAS GIVEN 1L FLUID AND A RAMP STUDY WAS PERFORMED BY THE PHYSICIAN. THE PT'S PUMP SPEED WAS INCREASED AGAIN FROM 8600 RPM TO 9200 RPM. SINCE THEN THE LOW FLOW ALARMS RESOLVED. THE SYSTEM CONTROLLER WAS ALSO EXCHANGED TO ENSURE THERE WAS NO ISSUE WITH THE PRIMARY SYSTEM CONTROLLER. THERE WERE NO ISSUES AND THE PUMP PARAMETERS STAYED THE SAME. ADDITIONAL INFO WAS RECEIVED FROM THE VAD COORD ON (B)(6) 2014 THAT THE PT RECEIVED A HEART TRANSPLANT THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587673 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 135845

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention