BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURDIAL X

    MDR report key: 12276617 · Received August 4, 2021

    Report

    Report Number
    3016250252-2021-00001
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    April 3, 2020
    Report Date
    August 4, 2021
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    PMA / PMN Number
    K182940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER EVALUATED THE DEVICE IN QUESTION AND DETERMINED THAT THE DEVICE IS SIMILAR TO 510K# K182940, THEREFORE MDR REPORTABILITY WAS DETEMINED ON JULY 8, 2021.

    Description of Event or Problem · 1

    DURING A DIALYSIS SESSION A PATIENT HAD TO BE PLACED IN INTENSIVE CARE WITH THE DIAGNOSIS OF HIGH POTASSIUM LEVEL AND HIGH WEIGHT GAIN, BECAUSE ALL THE ISOLATED ULTRA FILTRATION (ISO-UF) BUTTONS IN THE TREATMENT PROFILE WERE INADVERTENTLY SWITCH TO "ON" BY THE HEALTHCARE PROFESSIONAL WHILE SETTING THE NIPRO SURDIAL¿ X MACHINE. DUE TO THE ACCIDENTAL ACTIVATION OF ALL ISO-UF BUTTONS, THE POTASSIUM LEVEL ROSE TO A LIFE THREATENING LEVEL AND THE PATIENT WAS RESUSCITATED BECAUSE THE PATIENT WAS BRIEFLY UNCONSCIOUS WITH NO PULSE DETECTABLE. THE PATIENT WAS TREATED WITH 500 ML OF NACL (SODIUM CHLORIDE) IN THE ICU AND ONCE REANIMATED RECEIVED A DIALYSIS SESSION OF 5 HOURS BY USING ANOTHER MACHINE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173601 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization