BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE

    MDR report key: 4131324 · Received September 18, 2014

    Report

    Report Number
    4131324
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 9, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDISYSTEMS CORP.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WANTED TO USE THE RESTROOM, SO HEMODIALYSIS TECHNICIAN REINFUSED THE PATIENT'S BLOOD ACCORDING TO PROTOCOL. PATIENT WAS DISCONNECTED FROM DIALYSIS MACHINE AND WENT TO THE BATHROOM, HEMODIALYSIS TECHNICIAN HOOKED UP THE PATIENT'S CIRCUIT TO SALINE TO RECIRCULATE THE MACHINE, AND NOTICED THE ARTERIAL STREAMLINE POD WAS DEFLATED, BY PROCEDURE TO FIX THIS HEMODIALYSIS TECHNICIAN UNHOOKED THE LINE ATTACHED TO THE TRANSDUCER WHILE THE PUMP WAS OFF TO FILL THE ARTERIAL POD. INSTEAD OF THE POD FILLING IT LEAKED OUT INTO THE LINE, WHICH IS NOT SUPPOSED TO OCCUR. HEMODIALYSIS TECHNICIAN TOOK DOWN THIS SETUP AND PRIMED A NEW SYSTEM. PATIENT WAS SAFELY PUT BACK ON THE MACHINE AND RESUMED TREATMENT.REPORTED TO MEDISYSTEMS AND THEY ARE SENDING A BOX TO SEND THE TUBING TO THEM FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579013 STREAMLINE TUBING, DIALYSIS FJK MEDISYSTEMS CORP. SL-200M2095 40655095

    Patients

    Seq Age Sex Outcome Treatment
    1 *