BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURDIAL X

    MDR report key: 12283271 · Received August 5, 2021

    Report

    Report Number
    3016250252-2021-00011
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    April 1, 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
    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

    2 HOURS AFTER THE BEGINNING OF A DIALYSIS SESSION, A PATIENT REACTION OCCURRED WHILE USING THE NIPRO BRANDED DIALYSIS MACHINE SURDIAL¿ X BEARING SERIAL NUMBER19DN0750. THE PATIENT EXPERIENCED VOMITING, ACIDOSIS, RAISED OF PCO2 (HYPERCAPNEA) AND ALSO FELT DROWSY POSSIBLY DUE TO HYPOVENTILATION. THE MACHINE DID NOT PROVIDE ANY ALARM. AS A CONSEQUENCE, THE PATIENT WAS ADMITTED TO THE ICU. IT WAS ALSO REPORTED THAT THE PATIENT WAS FINE BEFORE THE TREATMENT AND NO MEDICATIONS WERE GIVEN BEFORE STARTING THE SESSION. NEVERTHELESS THE CURRENT PATIENT CONDITIONS ARE GOOD. AFTER THE INCIDENT OCCURRED, THE TECHNICIAN CARRIED OUT A SIMULATED TREATMENT ON THE MACHINE ALTHOUGH NO ERRORS OR FAULTS WERE FOUND DURING THE INVESTIGATION.

    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

    2 HOURS AFTER THE BEGINNING OF A DIALYSIS SESSION, A PATIENT REACTION OCCURRED WHILE USING THE NIPRO BRANDED DIALYSIS MACHINE SURDIAL¿ X BEARING SERIAL NUMBER (B)(4). THE PATIENT EXPERIENCED VOMITING, ACIDOSIS, RAISED OF PCO2 (HYPERCAPNIA) AND ALSO FELT DROWSY POSSIBLY DUE TO HYPOVENTILATION. THE MACHINE DID NOT PROVIDE ANY ALARM. AS A CONSEQUENCE, THE PATIENT WAS ADMITTED TO THE ICU. IT WAS ALSO REPORTED THAT THE PATIENT WAS FINE BEFORE THE TREATMENT AND NO MEDICATIONS WERE GIVEN BEFORE STARTING THE SESSION. NEVERTHELESS THE CURRENT PATIENT CONDITIONS ARE GOOD. AFTER THE INCIDENT OCCURRED, THE TECHNICIAN CARRIED OUT A SIMULATED TREATMENT ON THE MACHINE ALTHOUGH NO ERRORS OR FAULTS WERE FOUND DURING THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180154 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HD-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization