BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOMEDICS TOP HAT

    MDR report key: 2854602 · Received September 25, 2012

    Report

    Report Number
    2854602
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    May 2, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME IN WITH SEVERE AORTIC STENOSIS. HAD MECHANICAL AORTIC VALVE REPLACEMENT (AVR) DONE AND HAD MOVED OUT OF CARDIOVASCULAR RECOVERY (CVR) TO CARDIOVASCULAR SURGICAL UNIT (CVSU). AT ABOUT 1500, THE FATHER WAS WITH PATIENT AND PATIENT STOPPED TALKING AND STARED OFF AND WOULD NOT ANSWER. RAPID RESPONSE TEAM (RRT) CALLED AND THE PATIENT WAS EVALUATED. HIS CO2 WAS HIGH; SLOWLY NEURO STATUS RETURNED TO ALMOST BASELINE. THE PATIENT WAS TRANSFERRED TO CVR AND HAD ECHO AND HEART CATH NEXT DAY SHOWED AORTIC VALVE NOT WORKING CORRECTLY. IT APPEARED ONE LEAFLET WAS NOT OPENING AS IT SHOULD. THE DOCTOR WENT IN AND REPLACED THE VALVE. THE PATIENT REMAINED ON A VENTILATOR FOR SEVERAL DAYS AND WAS EXTUBATED THE FOLLOWING WEEKEND AND RETURNED TO CVSU 5 DAYS LATER. HE WAS ABLE TO COMMUNICATE FAIRLY WELL BUT SPEECH WAS SLOW AS WELL AS COMPREHENSION. TRANSFERRED TO REHAB TWO DAYS LATER IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS TOP HAT HEART VALVE, MECHANICAL LWQ SORIN GROUP USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR
    2