BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 11684817 · Received April 19, 2021

    Report

    Report Number
    11684817
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 29, 2021
    Report Date
    March 31, 2021
    Manufacturer
    GAMBRO DASCO SPA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RUNNING DIALYSIS AND MACHINE WENT INTO 320 ALARM GENERALS SYSTEM FAILURE. THE PATIENT WAS RINSED BACK MANUALLY. THE MACHINE WAS CHANGED OUT. A WORK ORDER WAS CALLED TO BIOMED. MANUFACTURER RESPONSE FOR HEMODIALYSIS UNIT, BAXTER - GAMBRO (PER SITE REPORTER). STAFF STATED ERROR 320 GENERAL SYSTEM FAILURE. WHEN I POWERED UP UNIT, IT GAVE SAME ERROR. A HOSE WAS NOTICED TO HAVE CAME OFF OUT OF THE 90 DEGREE ELBOW OFF THE BACK OF THE PO TRANSDUCER AND WAS LEAKING DOWN ONTO THE STERILANT PUMPS. REPLACED ELBOW AND FOUND THAT THE PUF HAD SIGNIFICANT WATER LEAKED ONTO IT. I UNPLUGGED PUF PUMP AND POWERED UNIT ON AND IT DID NOT ERROR. SO, I REPLACED THE PUF PUMP WITH A NEW ONE. RAN RINSE BECAUSE UNIT SHUT DOWN DURING TREATMENT IT KEPT TRYING TO FIND OLD TREATMENT PARAMETERS. CALLED BAXTER AND THEY SAID MY DIAGNOSIS AND REPAIR WAS CORRECT AND IF IT PASSED PATIENT SIMULATION TO RETURN IT BACK TO USE. RAN PATIENT SIM SUCCESSFULLY. RAN BLEACH AND RINSE AND RETURNED TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588306 PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DASCO SPA PHOENIX

    Patients

    Seq Age Sex Outcome Treatment
    1