BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 12609373 · Received October 11, 2021

    Report

    Report Number
    3016250252-2021-00027
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    June 24, 2021
    Report Date
    November 22, 2022
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    PMA / PMN Number
    K182940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITINOAL INFORMATION RECEIVED FROM THE USER: THE NURSE WAS CHECKED BY A PHYSICIAN. SHE RECEIVED MEDICAL TREATMENT/COVERAGE WITH WOUND GAUZE TO SUPPORT THE HEALING ON THE LEG. THE NURSE IS CURRENTLY RECOVERED WITH MINOR MARKS REMAINING ON THE SKIN. SECTION 5 OF THE MANUFACTURER REPORT ATTACHED HAS THE FOLLOWING WARNINGS WHICH ARE ALREADY INCLUDED IN THE MACHINE'S INSTRUCTION MANUAL AND ARE CONTINUALLY REMINDED IN THE INSTRUCTION MANUAL. 6.3. CHECK DURING CLEANING OPERATION. WARNING: THE SURFACES OF EXTERIOR PARTS AND SILICONE TUBES BECOME HOT DURING THE HOT RINSE AND HOT DISINFECTION OPERATIONS. HANDLE WITH CARE NOT TO GET BURN INJURY. THE INSIDE OF THE DIALYSATE CIRCUIT BECOMES VERY HOT DURING THE HOT RINSE AND HOT DISINFECTION OPERATIONS. DO NOT OPERATE WITH UNCOVERED MACHINE. TEMPERATURES OF SOLUTION MAY RISE TO NEARLY 100°C DURING THE HOT RINSE AND HOT DISINFECTION OPERATIONS. DO NOT TOUCH SPILLS WHEN LEAKAGE IS FOUND. YOU MAY GET BURNED.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED ABOUT AN INCIDENT WHERE A NURSE HAD CONTACT WITH HOT WATER WHILE CLEANING THE HEMODIALYSIS MACHINE. THE MACHINE WAS PUT INTO HOT DISINFECTION AND THE NURSE CONTINUED CLEANING / DISINFECTING THE SURFACE OF THE MACHINE. WHILE SHE WAS DOING THIS, SUDDENLY THE SILICONE TUBE FROM THE B-NOZZLE (BICARB NOZZLE) ON THE BSP PANEL (BLOOD PUMP / SYRINGE PUMP PANEL) SIDE "POPPED-OFF" AND HOT WATER WAS SPILLED OVER HER LEG. SHE WAS SUFFERING AND SHOWING SIGNS OF SCALDING. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 1

    WE HAVE BEEN INFORMED ABOUT AN INCIDENT WHERE A NURSE HAD CONTACT WITH HOT WATER WHILE CLEANING THE HEMODIALYSIS MACHINE. THE MACHINE WAS PUT INTO HOT DISINFECTION AND THE NURSE CONTINUED CLEANING / DISINFECTING THE SURFACE OF THE MACHINE. WHILE SHE WAS DOING THIS, SUDDENLY THE SILICONE TUBE FROM THE B-NOZZLE (BICARB NOZZLE) ON THE BSP PANEL (BLOOD PUMP / SYRINGE PUMP PANEL) SIDE "POPPED-OFF" AND HOT WATER WAS SPILLED OVER HER LEG. SHE WAS SUFFERING AND SHOWING SIGNS OF SCALDING. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504290 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM HEMODIALYSIS MACHINE KDI SHIBUYA (SBY)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other