BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURDIAL X

    MDR report key: 12278675 · Received August 4, 2021

    Report

    Report Number
    3016250252-2021-00006
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    March 25, 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 DETERMINED ON JULY 8, 2021.

    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

    IT WAS REPORTED THAT A PATIENT SHOWED SYMPTOMS OF HYPOTENSION DURING DIALYSIS SESSION. CLINICAL STAFF ALSO REPORTED EXCESSIVE WEIGHT REMOVAL (ULTRAFILTRATION) DURING DIALYSIS TREATMENT. THIS HAS BEEN CONFIRMED BY CHECKING THE PATIENT'S WEIGHT BEFORE AND AFTER THE DIALYSIS TREATMENT. (B)(6). PATIENT WELL ENOUGH TO GO HOME AFTER FINISHING THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT SHOWED SYMPTOMS OF HYPOTENSION DURING DIALYSIS SESSION. CLINICAL STAFF ALSO REPORTED EXCESSIVE WEIGHT REMOVAL (ULTRAFILTRATION) DURING DIALYSIS TREATMENT. THIS HAS BEEN CONFIRMED BY CHECKING THE PATIENT'S WEIGHT BEFORE AND AFTER THE DIALYSIS TREATMENT. PATIENT DETAILS PRE-DIALYSIS: WEIGHT 73.0 KG, BLOOD PRESSURE (BP) 144/82, PULSE 88. PLANNED FLUID REMOVAL OF 2.3L. PATIENT BLOOD PRESSURE RECORDED, DROPPED FROM 144/82 PRE-DIALYSIS SESSION AT 08:45 TO 89/54 AT 11:39 AFTER ROUTINE DIALYSIS TREATMENT. PATIENT WEIGHT LOSS (ULTRAFILTRATION) WAS RECORDED AS EXCESSIVE TO THAT PROGRAMMED ON THE DIALYSIS MACHINE BY 700ML (0.7KG). THE HEMODIALYSIS TREATMENT STARTED AT 08:45 AM. AT 11:30 AM: BLOOD PRESSURE: 93/57, NORMAL SALINE 200 MLS GIVEN, PLANNED FLUID REMOVAL DECREASED TO 2.0L, 11:39 AM: BLOOD PRESSURE 89/54, NORMAL SALINE 200 MLS GIVEN TO THE PATIENT, ULTRA-FILTRATION STOPPED, RECORDED FLUID REMOVED 1.88L. POST HEMO-DIALYSIS WEIGHT 71.3KG. PATIENT WELL ENOUGH TO GO HOME AFTER FINISHING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174858 SURDIAL X HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) SURDIAL-X2-HD-UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention