BEUDAMED
    FDA Adverse Event Summary report: N

    SENSATION

    MDR report key: 2250828 · Received September 12, 2011

    Report

    Report Number
    2250828
    Date Received
    September 12, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 29, 2011
    Manufacturer
    CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
    Product Code
    DSP
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DATASCOPE IABP DISPLAYED "OPTICAL" ALARM AND THEN SELF-RESOLVED AND THE DEVICE (IAB CATHETER) WAS WEANED AND REMOVED FROM THE PATIENT. THERE WERE NO PATIENT ISSUES AND NO HARM TO THE PATIENT. THE CENTRAL LUMEN APPEARED CLOTTED. PATIENT WAS IN THE OR AND NOT OFF HEART PUMP SO THE BALLOON PUMP WAS USED FOR LEFT VENTRICLE ASSISTANCE. STAFF THOUGHT THIS MAY HAVE BEEN A "LIGHT SENSOR PROBLEM" DUE TO ALARMING. STAFF ALSO THOUGHT THE INTER-LUMEN MAY NOT HAVE BEEN PRE-FLUSHED WITH HEPARIN OR MAY HAVE BEEN "PUSHED HARD AND BROKEN FIBER-OPTIC TIP OR CLOTTED OR CLOGGED THE DEVICE (CATHETER)". THERE ARE A FEW THEORIES, BUT NO ONE IS SURE WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION CATHETER, INTRA-AORTIC BALLOON DSP CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC 0684-00-0470-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *