BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 4995030 · Received July 31, 2015

    Report

    Report Number
    3003263092-2015-00027
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    October 14, 2013
    Report Date
    October 14, 2013
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    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

    THE REPORTED PICCO CATHETER WAS RETURNED FOR INVESTIGATION. THE REPORTED PROBLEM COULD BE CONFIRMED BY OCULAR INSPECTION. THE ROOT CAUSE FOR THE DISCONNECTION IS SEEN IN 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 THE LUER LOCK DETACHED FROM THE EXTENSION LINE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502419 PULSION PULSIOCATH THERMODILUTION CATHETERS KRB KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1