BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 4994993 · Received July 31, 2015

    Report

    Report Number
    3003263092-2015-00009
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    March 2, 2014
    Report Date
    March 3, 2014
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    THE PICCO CATHETER THAT WAS USED DURING THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE IT IS NOT POSSIBLE TO CONFIRM IF THERE WAS A MALFUNCTION OR ANY DEVIATION FROM THE SPECIFICATION. THE REPORTED MALPERFUSION IS A KNOWN COMPLICATION OF ARTERIAL CANNULATION. PLEASE NOTE, THIS EVENT IS BEING FILED AS A RETROSPECTIVE MDR AS A RESULT OF A REVIEW OF OUR COMPLAINT DATABASE.

    Description of Event or Problem · 1

    A PICCO CATHETER DESIGNED FOR PLACEMENT IN THE BRACHIAL ARTERY WAS PLACED IN THE RADIAL ARTERY. THIS WAS BASED ON THE DOCTORS ASSESSMENT, THAT THE OUTER DIAMETER OF THE CATHETER IS FINE FOR THE RADIAL ARTERY, TOO. AFTER SOME HOURS SIGNS OF MALPERFUSION IN THE HAND (COLD HAND, WEAK SPO2 SIGNAL) WERE DETECTED AND THE CATHETER WAS REMOVED. THEREAFTER THE SITUATION IMPROVED AGAIN AND THE PATIENT WAS NOT INJURED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502380 PULSION PULSIOCATH THERMODILUTION CATHETERS KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability