BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 8416282 · Received March 13, 2019

    Report

    Report Number
    8416282
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    January 12, 2019
    Report Date
    January 16, 2019
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PLUGGED DIALYSIS MACHINE INTO RED OUTLET ON MEDICAL INTENSIVE CARE UNIT (MICU) ROOM. ELECTRICAL SPARK AND SMOKE OCCURRED. MACHINE WAS NOT YET POWERED UP. BLACK RESIDUE ON NURSES GLOVE. NO ELECTRICAL BURN TO NURSE. MACHINE TAKEN OUT OF SERVICE, ELECTRICIAN CALLED TO CHECK OUTLET. DIALYSIS RN SEEN BY ENVIRONMENT, OCCUPATIONAL HEALTH AND SAFETY (EOHS) AND REPORTED INCIDENT. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209468 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC K SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA