BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURDIAL X

    MDR report key: 12287471 · Received August 6, 2021

    Report

    Report Number
    3016250252-2021-00023
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    December 21, 2021
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    PMA / PMN Number
    K182940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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

    THE DIALYSIS MACHINE WAS GIVING AN ARTERIAL PRESSURE ALARM. THIS ALARM HAD BEEN RESET AND AFTER THIS, AN AIR BUBBLE DETECTION ALARM OCCURRED. THE CLAMPS OF THE DEVICE AND THE CATHETER HAD BEEN CLOSED TO ENSURE THE PATIENT'S SAFETY. THE CATHETER HAD BEEN FLUSHED ONCE AND RECONNECTED TO CONTINUE TREATMENT, THEN IT WAS NOTICED THAT ARTERIAL AIR HAD ENTERED THE CIRCUIT. PATIENT BECAME DIZZY AND UNWELL. AS A FIRST INTERVENTION THE PATIENT WAS PLACED IN TRENDLENBURG POSITION AND ON THE LEFT SIDE. OXYGEN WAS PROVIDED VIA AN OXYGEN MASK. PATIENT WAS DISCONNECTED AND HAD A GOOD RECOVERY. EKG (ELECTROCARDIOGRAPH), TTE (TRANSTHORACIC ECHOCARDIOGRAM) AND CT ANGIOGRAPHY WERE ORDERED BY THE PHYSICIAN. NO FURTHER INFORMATION HAS BEEN 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 JULY 8, 2021.

    Description of Event or Problem · 1

    THE DIALYSIS MACHINE WAS GIVING AN ARTERIAL PRESSURE ALARM. THIS ALARM HAD BEEN RESET AND AFTER THIS, AN AIR BUBBLE DETECTION ALARM OCCURRED. THE CLAMPS OF THE DEVICE AND THE CATHETER HAD BEEN CLOSED TO ENSURE THE PATIENT'S SAFETY. THE CATHETER HAD BEEN FLUSHED ONCE AND RECONNECTED TO CONTINUE TREATMENT, THEN IT WAS NOTICED THAT ARTERIAL AIR HAD ENTERED THE CIRCUIT. PATIENT BECAME DIZZY AND UNWELL. AS A FIRST INTERVENTION THE PATIENT WAS PLACED IN TRENDELENBURG POSITION AND ON THE LEFT SIDE. OXYGEN WAS PROVIDED VIA AN OXYGEN MASK. PATIENT WAS DISCONNECTED AND HAD A GOOD RECOVERY. EKG (ELECTROCARDIOGRAPH), TTE (TRANSTHORACIC ECHOCARDIOGRAM) AND CT ANGIOGRAPHY WERE ORDERED BY THE PHYSICIAN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186761 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HFDP-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention