BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMCATH

    MDR report key: 5555103 · Received April 7, 2016

    Report

    Report Number
    3004367028-2016-00003
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    March 1, 2016
    Report Date
    April 7, 2016
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K100451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    N.A.

    Description of Event or Problem · 1

    A PATIENT IN SWEDEN WAS UNDERGOING A DIALYSIS TREATMENT VIA A GAM CATH MS-GDHK 1320 VASCULAR ACCESS CATHETER. THE PATIENT WAS TEMPORARILY DISCONNECTED FROM THE DIALYSIS MACHINE TO UNDERGO A DIAGNOSTIC TEST. WHEN THE NURSE WENT TO RECONNECT THE PATIENT TO THE CATHETER SHE HEARD A CRACK AND OBSERVED A BLOOD LEAK. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER. THE EXACT DATE OF THIS EVENT IS UNKNOWN AND THEREFORE THE DATE OF THE EVENT IN THIS REPORT IS AN ESTIMATED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209437 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH MS-GDHK-1320 DOLPHIN 2015-10-1794 (OR 2015-09-1721)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 Required Intervention