BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12280870 · Received August 5, 2021

    Report

    Report Number
    3016250252-2021-00008
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    April 2, 2021
    Report Date
    December 20, 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

    CUSTOMER STATED THAT THE FOLLOWING DATA RELATED TO AN EVENT OF ULTRA FILTRATION INACCURACY REGISTERED DURING A DIALYSIS TREATMENT WHILE USING THE NIPRO SURDIAL X MACHINE BEARING SERIAL NUMBER (B)(6). PATIENT'S WEIGHT ON ADMISSION WAS 76.2KG, PROGRAMMED ULTRA FILTRATION WAS 2.3 KG. PATIENT'S BLOOD PRESSURE DROPPED TO 83/45 AND WAS GIVEN SALINE 200MLS VOLUME. PATIENT'S FINAL WEIGHT UPON COMPLETION OF TREATMENT WAS 75.4KG. TOTAL AMOUNT OF FLUID REMOVED DURING TREATMENT WAS NOT RECORDED. PATIENT'S ULTRAFILTRATION RATIO (UFR) WAS REDUCED TO 1.4. NO FURTHER INFORMATION WAS 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

    CUSTOMER STATED THAT THE FOLLOWING DATA RELATED TO AN EVENT OF ULTRA FILTRATION INACCURACY REGISTERED DURING A DIALYSIS TREATMENT WHILE USING THE NIPRO SURDIAL X MACHINE BEARING SERIAL NUMBER (B)(4). PATIENT'S WEIGHT ON ADMISSION WAS (B)(6), PROGRAMMED ULTRA FILTRATION WAS (B)(6). PATIENT'S BLOOD PRESSURE DROPPED TO 83/45 AND WAS GIVEN SALINE 200MLS VOLUME. PATIENT'S FINAL WEIGHT UPON COMPLETION OF TREATMENT WAS (B)(6). TOTAL AMOUNT OF FLUID REMOVED DURING TREATMENT WAS NOT RECORDED. PATIENT'S ULTRAFILTRATION RATIO (UFR) WAS REDUCED TO 1.4. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178948 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HD-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other