BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12278632 · Received August 4, 2021

    Report

    Report Number
    3016250252-2021-00005
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    March 25, 2021
    Report Date
    December 2, 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 DURING A DIALYSIS SESSION (ULTRA FILTRATION(UF) GOAL OF 0.5 L OVER 4.5 HOURS) RUN, THE MACHINE WAS SHOWN TO BE REMOVING 3 TIMES AS MUCH FLUID AS PROGRAMMED. AS A CONSEQUENCE, THE PATIENT BECAME UNWELL AFTER HIS BLOOD PRESSURE DROPPED. HE WAS CONSCIOUS, NAUSEATED AND THEN SUBSEQUENTLY VOMITED. THEREFORE, THE MEDICAL STAFF ADMINISTERED APPROXIMATELY 500MLS - 1 LITRE OF SALINE. THE PATIENT THEN RECOVERED AND THE ULTRA FILTRATION WAS STOPPED FOR THE REMAINING TIME ON DIALYSIS. AFTER THE TREATMENT THE PATIENT WAS IN A SATISFACTORY CONDITION TO GO HOME.

    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 DURING A DIALYSIS SESSION (ULTRA FILTRATION(UF) GOAL OF 0.5 L OVER 4.5 HOURS) RUN, THE MACHINE WAS SHOWN TO BE REMOVING 3 TIMES AS MUCH FLUID AS PROGRAMMED. AS A CONSEQUENCE, THE PATIENT BECAME UNWELL AFTER HIS BLOOD PRESSURE DROPPED. HE WAS CONSCIOUS, NAUSEATED AND THEN SUBSEQUENTLY VOMITED. THEREFORE, THE MEDICAL STAFF ADMINISTERED APPROXIMATELY 500 MLS - 1 LITRE OF SALINE. THE PATIENT THEN RECOVERED AND THE ULTRA FILTRATION WAS STOPPED FOR THE REMAINING TIME ON DIALYSIS. AFTER THE TREATMENT THE PATIENT WAS IN A SATISFACTORY CONDITION TO GO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175111 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HD-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention