BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12285088 · Received August 5, 2021

    Report

    Report Number
    3016250252-2021-00015
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    April 15, 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

    DURING DIALYSIS TREATMENT, THE MACHINE'S ULTRAFILTRATION WAS PROGRAMMED TO TAKE 1.7L OFF, BUT INSTEAD REMOVED 2.4L. PATIENT WAS ASYMPTOMATIC. PATIENT'S LOWEST BLOOD PRESSURE WAS 127/49. 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 DETERMINED ON (B)(6) 2021.

    Description of Event or Problem · 1

    DURING DIALYSIS TREATMENT, THE MACHINE'S ULTRAFILTRATION WAS PROGRAMMED TO TAKE 1.7L OFF, BUT INSTEAD REMOVED 2.4L. PATIENT WAS ASYMPTOMATIC. PATIENT'S LOWEST BLOOD PRESSURE WAS 127/49. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176728 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HD-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other