BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4223233 · Received October 27, 2014

    Report

    Report Number
    2916596-2014-01942
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 29, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE MANUFACTURER'S ANALYSIS OF THE HISTORICAL LOG FILE DATA DOWNLOADED FROM THE PATIENT'S SYSTEM CONTROLLER CONFIRMED THE REPORT OF LOW FLOW HAZARD ALARMS; HOWEVER, A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED. THE DATA RECORDED IN THE HISTORICAL LOG FILE REVEALED LOW FLOW HAZARDS EVENTS CAPTURED WITH THE RECORDED ESTIMATED FLOW RATES OF 2.4 LITERS PER MINUTE (LPMS). THE INFORMATION AVAILABLE TO THE MANUFACTURER INDICATED THAT THE REPORTED SYMPTOMS RESOLVED AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. THE DEVICE'S APPROVED LABELING PROVIDES INFORMATION REGARDING THE FACTORS THAT AFFECT PUMP FLOW AND HOW TO ASSESS FLOW. THE USE OF ANTICOAGULATION MEDICATION IS OUTLINED IN DEVICE'S LABELING. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT. (B)(4).

    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 THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 FOR SUSPICION OF A TRANSIENT ISCHEMIC ATTACK. THE PATIENT'S INR WAS 1.2, AND HER PLASMA FREE HEMOGLOBIN WAS 79. LOW FLOW ALARMS WERE OCCURRING INTERMITTENTLY. AN ECHO WAS PERFORMED. THE HOSPITAL STAFF INCREASED THE PATIENT'S DOSAGE OF ASPIRIN AND WILL MONITOR HER CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681375 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 110013

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention