BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLO IIS

    MDR report key: 8342338 · Received February 15, 2019

    Report

    Report Number
    9617473-2017-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    PMA / PMN Number
    K082758
    Removal / Correction Number
    Z-0759-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION IS THAT THE HEATING WIRE OF THE HEATING PROFILE WAS INTERNALLY DAMAGED DUE TO EXTERNAL MECHANICAL STRESS ADDITIONALLY THE HEATING PROFILE WAS PARTLY COVERED BY PATIENTS ARM AND FLANK. THERE IS ALSO A STRONG DOUBT IF THE CLEANING AND DISINFECTING METHODS (ONLY WITH ALCOHOL-BASED DISINFECTANT AGENTS OR READY-TO-USE DISINFECTANTS) FOR THE HEATING PROFILE WERE FOLLOWED CORRECTLY (ACCORDING THE INSTRUCTIONS FOR USE). THE COMBINATION OF THESE FACTORS MUST HAVE LEAD TO THE LOCAL OVERHEATING OF THE HEATING PROFILE AND CONSEQUENTLY TO THE TWO BURN MARKS ON RIGHT ARM AND FLANK. THE BURN MARKS WERE SMALL AND NOT JUDGED A SERIOUS INJURY. BECAUSE OF THE CHARACTERISTICS OF THIS EVENT, THE MANUFACTURER JUDGES THAT THIS EVENT FITS IN THE RECALL OF THIS PRODUCT THAT ADDRESSES THE POTENTIAL FAILURE. AS SOON AS THE HEALTHCARE PROVIDER RESPONDS TO THE "URGENT MEDICAL DEVICE CORRECTION" FORM FROM STIHLER ELECTRONIC THE AFFECTED HEATING PROFILES WILL BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A BLOOD WARMER PRISMAFLO IIS, THE NURSE NOTICED THAT THE HEATING PROFILE OF THE BLOOD WARMER WAS HOT AND SMOKING. THE PATIENT SUFFERED AT LEAST TWO SECOND DEGREE BURNS. TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139285 PRISMAFLO IIS BLOOD WARMER KOC STIHLER ELECTRONIC GMBH PF2-WP33

    Patients

    Seq Age Sex Outcome Treatment
    1