BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911705 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00850
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORT OF LOW FLOW HAZARD ALARMS, POWER ELEVATIONS, AND A PUMP STOPPAGE EVENT WAS CONFIRMED BASED ON THE EVALUATION OF THE LOG FILE THAT WAS SUBMITTED AT THE TIME OF THE EVENT; HOWEVER, A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IN ADDITION, HEMOLYSIS IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. 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.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL OVERNIGHT. THE PT STATED THAT HIS PUMP WAS FEELING WEIRD OVER THE WEEKEND. ON INTERROGATION IT WAS NOTED IN THE EVENT HISTORY THAT THE PT HAD A "PUMP OFF" ON (B)(6) 2014. THE PT HAS A HISTORY OF LDH AS HIGH AS 1315, BUT IT IS CURRENTLY 629. HIS INR GOAL IS 2.5-3.5 AND HE HAS BEEN THERAPEUTIC. HE IS ALSO ON FULL DOSE ASPIRIN AND PERSANTINE. THE PT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314828 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 135852

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention