BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSIOCATH PICCO MONITORING KIT

    MDR report key: 4995014 · Received July 31, 2015

    Report

    Report Number
    3003263092-2015-00012
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K020587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE IT IS NOT POSSIBLE TO CONFIRM IF THERE WAS A MALFUNCTION OR ANY DEVIATION FROM THE SPECIFICATION. OUR SUPPLIER INVESTIGATED A PRODUCT OF THE SAME BATCH AND DID NOT FIND ANY DEVIATIONS FROM THE SPECIFICATION. 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 LUER LOCK CONNECTIONS OF A PICCO MONITORING KIT WERE LOOSE DURING USE ON A PATIENT. NO KNOWN IMPACT OR CONSEQUENCES TO PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501451 PULSIOCATH PICCO MONITORING KIT KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1