BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 4996378 · Received August 7, 2015

    Report

    Report Number
    3003263092-2015-00031
    Event Type
    Death
    Date Received
    August 7, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K072364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    PT HAD A FEMORAL PICCO CATHETER PLACED. PT WAS EXTREMELY UNWELL ANYWAY, BUT IT WAS NOTED THAT CIRCULATION TO THE LEG WAS REDUCED. IN THE LATER COURSE THE PT DIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521401 PULSION PULSIOCATH THERMODILUTION CATHETERS KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death