BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 25073649 · Received May 4, 2026

    Report

    Report Number
    1056186-2026-00017
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    October 22, 2025
    Report Date
    May 4, 2026
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    UDI-DI
    00383790008815
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED CONDITION: CUSTOMER REPORTED THAT SCREW WAS MISSING FROM ROTOR. THE NATIONAL SERVICE AFTER INVESTIGATING, IDENTIFIED THAT 1 OF THE 2 SCREWS HOLDING THE BLOOD PUMP ROTOR FACEPLATE WAS MISSING. ORIGINAL BLOOD PUMP ROTOR GAP AND OCCLUSION PRESSURE ARE WITHIN MANUFACTURE'S SPECIFICATIONS. PERFORMED A VISUAL INSPECTION OF THE BLOOD PUMP MODULE AND ONLY LOCATED THE MISSING FACEPLATE SCREW ON THE BLOOD PUMP ROTOR, NO OTHER ABNORMALITIES IDENTIFIED. INSTALLED THE NEW BLOOD PUMP ROTOR AND PROCEEDED WITH PERFORMING THE BLOOD PUMP OCCLUSION CALIBRATION TO MANUFACTURE SPECIFICATIONS. FOLLOWED UP WITH A SIMULATED TREATMENT TO VERIFY PROPER OPERATION OF THE DEVICE. ADJUSTED THE BLOOD PUMP SPEED DURING TESTING TO ENSURE THE BLOOD PUMP MODULE WAS WORKING TO MANUFACTURE SPECIFICATIONS AND NO ISSUES OR ALARMS IDENTIFIED DURING TESTING. COMPLETED A HEAT CITRIC DISINFECTION AFTER DEVICE VERIFICATION PROCESS. MACHINE HAS BEEN TESTED, VERIFIED, AND DISINFECTED PER IFU. SDX IS OPERATING TO MANUFACTURE SPECIFICATIONS AND RELEASED FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323824 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01 00383790008815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other