BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 4994983 · Received July 31, 2015

    Report

    Report Number
    3003263092-2015-00007
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PICCO CATHETER WAS RETURNED FOR INVESTIGATION. THE REPORTED PROBLEM COULD BE CONFIRMED BY OCULAR INSPECTION. THE CAUSE TO THE DETACHMENT IS SEEN AS A PRODUCTION ERROR. 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

    IT WAS REPORTED THAT DURING USE OF A PICCO CATHETER ON A PATIENT, BLOOD BACK FLOW WAS FOUND IN THE CATHETER. NO KNOWN IMPACT OR CONSEQUENCES ON PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501496 PULSION PULSIOCATH THERMODILUTION CATHETERS KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1