BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSION PULISOCATH THERMODILUTION CATHETERS

    MDR report key: 5048887 · Received August 7, 2015

    Report

    Report Number
    3003263092-2015-00030
    Event Type
    Malfunction
    Date Received
    August 7, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    PULSION MEDICAL SYSTEMS AG
    Product Code
    KRB
    PMA / PMN Number
    K072364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS FINISHED.

    Description of Event or Problem · 1

    PATIENT HAD A BRACHIAL PICCO CATHETER PLACED. IT WAS NOTED THAT THE PATIENT HAD QUITE REDUCED BLOOD FLOW TO THE HAND., WHICH FELT COLD AND LOOKED PALE. IN VIEW OF THIS THE CATHETER WAS REMOVED. NO INFORMATION WAS RECEIVED REGARDING LONG-TERM EFFECTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521547 PULSION PULISOCATH THERMODILUTION CATHETERS KRB PULSION MEDICAL SYSTEMS AG

    Patients

    Seq Age Sex Outcome Treatment
    1