BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURDIAL X

    MDR report key: 12278030 · Received August 4, 2021

    Report

    Report Number
    3016250252-2021-00003
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    October 10, 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
    BE
    Reporter Occupation
    NURSE

    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 DETERMINED ON JULY 8, 2021.

    Description of Event or Problem · 1

    AN EPISODE OF AIR EMBOLISM OCCURRED WHILE USING THE NIPRO DIALYSIS MACHINE SURDIAL¿ X BEARING THE SERIAL NUMBER (B)(4). IT WAS CONFIRMED THAT THE ARTERIAL PRESSURE WAS STRONGLY NEGATIVE SINCE THE BEGINNING OF THE TREATMENT, BUT THE ALARM (E024) WAS RESET SEVERAL TIMES DURING THE DIALYSIS PROCESS BY THE NURSE WHO TRIED TO SOLVE THE ISSUE OF THE NEGATIVE PRESSURE BY DISCONNECTING THE ARTERIAL BLOODLINE AND CONNECTING A SYRINGE TO FLUSH THE CATHETER. FOLLOWING THAT OPERATION, THE PATIENT SHOWED SIGNS OF AIR EMBOLISM FEELING UNWELL FOR ABOUT 1 MINUTE. AS A CONSEQUENCE, THE DOCTOR ACTED FAST BY PLACING THE PATIENT IN A FLAT POSITION AND THE CONDITIONS STABILIZED. THE PATIENT HAD NO LASTING SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173375 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HFDP-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention