BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12287837 · Received August 6, 2021

    Report

    Report Number
    3016250252-2021-00025
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    April 30, 2021
    Report Date
    January 5, 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

    DURING THE REINFUSION, AFTER DIALYSIS TREATMENT, THE NURSE WITNESSED AIR PASSING THE CLAMP BOX, THROUGH THE VNOUS LINE WITHOUT THE MACHINE GIVING ANY ALARM OR OPERATING THE VENOUS CLAMP. THERE WERE NO INJURIES OR CONSEQUENCES TO THE PATIENT. INSPECTION WAS CARRIED OUT BY NIPRO SERVICE TECHNICIAN. THE TECH CHECKED THE CLAMP BOX FOR DAMAGE, THEN CHECKED ITS CALIBRATION. NO ADJUSTMENT NECESSARY. RAN MACHINE THROUGH A SIMULATED TREATMENT AND ACTIVATED THE AIR BUBBLE ALARM WITH ACTUAL AIR BUBBLES MANY TIMES AND SAW THAT THE CLAMP BOX WAS OPERATING CORRECTLY. DURING REINFUSION, THE TECH ALLOWED THE VENOUS CHAMBER RUN EMPTY AND THE VENOUS CLAMP AGAIN CLAMPED THE LINE AND THE AIR BUBBLE ALARM CAME UP. THE MACHINE IS CURRENTLY BEING USED AT THE FACILITY.

    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 THE REINFUSION, AFTER DIALYSIS TREATMENT, THE NURSE WITNESSED AIR PASSING THE CLAMP BOX, THROUGH THE VNOUS LINE WITHOUT THE MACHINE GIVING ANY ALARM OR OPERATING THE VENOUS CLAMP. THERE WERE NO INJURIES OR CONSEQUENCES TO THE PATIENT. INSPECTION WAS CARRIED OUT BY NIPRO SERVICE TECHNICIAN. THE TECH CHECKED THE CLAMP BOX FOR DAMAGE, THEN CHECKED ITS CALIBRATION. NO ADJUSTMENT NECESSARY. RAN MACHINE THROUGH A SIMULATED TREATMENT AND ACTIVATED THE AIR BUBBLE ALARM WITH ACTUAL AIR BUBBLES MANY TIMES AND SAW THAT THE CLAMP BOX WAS OPERATING CORRECTLY. DURING REINFUSION, THE TECH ALLOWED THE VENOUS CHAMBER RUN EMPTY AND THE VENOUS CLAMP AGAIN CLAMPED THE LINE AND THE AIR BUBBLE ALARM CAME UP. THE MACHINE IS CURRENTLY BEING USED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186441 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HDF-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other