BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12285339 · Received August 5, 2021

    Report

    Report Number
    3016250252-2021-00022
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    April 21, 2021
    Report Date
    December 20, 2022
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    PMA / PMN Number
    K182940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE SURDIAL¿ X DIALYSIS MACHINE REMOVED AN EXCESSIVE AMOUNT OF FLUID DURING THE DIALYSIS TREATMENT. THE PATIENT CAME OFF THE TREATMENT WITH 0.5KG UNDER THE TARGET WEIGHT. THE PATIENT WAS ASYMPTOMATIC. NO FURTHER INFORMATION WAS PROVIDED.

    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

    IT WAS REPORTED THAT THE SURDIAL¿ X DIALYSIS MACHINE REMOVED AN EXCESSIVE AMOUNT OF FLUID DURING THE DIALYSIS TREATMENT. THE PATIENT CAME OFF THE TREATMENT WITH 0.5 KG UNDER THE TARGET WEIGHT. THE PATIENT WAS ASYMPTOMATIC. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177030 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HD-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other