BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSON

    MDR report key: 5822907 · Received July 26, 2016

    Report

    Report Number
    3009498591-2016-00226
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    April 4, 2013
    Report Date
    July 27, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K071234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE PURPOSE OF IDENTIFYING CONCOMITANT DEVICES. THE REPORTED EVENT DESCRIBES SIDE EFFECTS FROM THE PROCEDURE OR PATIENT SYMPTOMS DUE TO THEIR CONDITION. THIS PRODUCT IS CONSIDERED A CONCOMITANT DEVICE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. A PERICARDIOCENTESIS WAS PERFORMED BUT NO FLUID COULD BE ASPIRATED, THEREFORE A PERICARDIAL WINDOW WAS PERFORMED. CALLER REPORTED THAT 200-300 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE INTUBATED, ON A BALLOON PUMP, AND IN STABLE CONDITION. THE FOLLOWING BWI DEVICES WERE IN USE: CARTO 3 (10143), STOCKERT ((B)(4)), COOL FLOW PUMP (03132), THERMOCOOL SF CATHETER (D131503, 15729403L - BEING RETURNED), LASSO CATHETER (122073S, 15786420L- BEING RETURNED), AND AN ACUNAV CATHETER (CATALOG AND LOT NUMBER UNKNOWN - NOT SURE IF IT IS BEING RETURNED AND NOT SURE IF IT WAS REPROCESSED OR NOT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475146 ACUSON DIAGNOSTIC ULTRASOUND DEVICE OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R