BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12288116 · Received August 6, 2021

    Report

    Report Number
    3016250252-2021-00026
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    June 24, 2021
    Report Date
    January 5, 2021
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    PMA / PMN Number
    K182940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 DETERMINED ON JULY 8, 2021.

    Description of Event or Problem · 0

    DURING DIALYSIS TREATMENT, THE NURSE STARTED NOTICING THAT MICROBUBBLES STARTED PASSING THROUGH THE AIR DETECTOR CHAMBER AND WAS ABOUT TO ENTER THE PATIENT. THE AIR DETECTOR FAILED TO ALARM. THE NURSE IMMEDIATELY STOPPED THE BLOOD PUMP AND RECIRCULATED THE LINES AGAIN TO GET RID OF THE AIR FROM THE BLOODLINES. FIVE MINUTED LATER, THE MACHINE'S ARTERIAL ALARM WENT OFF WITH -400MMHG PRESSURE. PATIENT FELT VERY UNWELL. 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

    DURING DIALYSIS TREATMENT, THE NURSE STARTED NOTICING THAT MICROBUBBLS STARTED PASSING THROUGH THE AIR DETECTOR CHAMBER AND WAS ABOUT TO ENTER THE PATIENT. THE AIR DETECTOR FAILED TO ALARM. THE NURSE IMMEDIATELY STOPPED THE BLOOD PUMP AND RECIRCULATED THE LINES AGAIN TO GET RID OF THE AIR FROM THE BLOODLINES. FIVE MINUTED LATER, THE MACHINE'S ARTERIAL ALARM WENT OFF WITH -400MMHG PRESSURE. PATIENT FELT VERY UNWELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183632 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other