BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12278723 · Received August 4, 2021

    Report

    Report Number
    3016250252-2021-00007
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    February 12, 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

    CUSTOMER REPORTED THAT 2 PATIENTS EXPERIENCED SYMPTOMATIC HYPOTENSION DURING DIALYSIS TREATMENT. PATIENTS ALSO CAME OFF FROM HEMODIALYSIS TREATMENT UNDER THE TARGET DRY WEIGHT WHEN THEY USED THE DIALYSIS MACHINE -16 . REVIEW OF THE PATENT'S NOTES EVIDENCED THAT , THE AFFECTED PATENTS HAD (UNPLANNED) EXTRA FLUID REMOVED ADDITIONAL TO THE TARGETED ULTRAFILTRATION. THE PATIENTS RECEIVED SALINE (UNSPECIFIED THE AMOUNT) AND WERE WELL ENOUGH TO BE DISCHARGED AFTER DIALYSIS TREATMENT.

    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

    CUSTOMER REPORTED THAT 2 PATIENTS EXPERIENCED SYMPTOMATIC HYPOTENSION DURING DIALYSIS TREATMENT. PATIENTS ALSO CAME OFF FROM HEMODIALYSIS TREATMENT UNDER THE TARGET DRY WEIGHT WHEN THEY USED THE DIALYSIS MACHINE -16 . REVIEW OF THE PATENT'S NOTES EVIDENCED THAT , THE AFFECTED PATENTS HAD (UNPLANNED) EXTRA FLUID REMOVED ADDITIONAL TO THE TARGETED ULTRAFILTRATION. THE PATIENTS RECEIVED SALINE (UNSPECIFIED THE AMOUNT) AND WERE WELL ENOUGH TO BE DISCHARGED AFTER DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174939 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HD-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention