BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLO IIS

    MDR report key: 10690473 · Received October 16, 2020

    Report

    Report Number
    9617473-2020-00001
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    PMA / PMN Number
    K082758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS CAUSED BY USER FAULT. PICTURES (PROVIDED BY THE HEALTH CARE FACILITY), THAT THERE HAS BEEN A MISUSE OF THE DEVICE. IN THE IFU AT FOUR DIFFERENT CHAPTERS THERE ARE PLACED WARNINGS - RISK OF OVERHEATING / DO NOT COVER (NOT EVEN PARTIALLY) THE HEATING PROFILE WHILE IN USE. ADDITIONALLY ON THE BLACK SHORT HOUSING OF THE HEATING PROFILE THERE IS PLACED A RED WARNING LABEL WITH THE SYMBOL "PROHIBITION: DO NOT COVER HEATING PROFILE - RISK OF OVERHEATING".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHYSICIAN AND BEDSIDE NURSE ENTERED PATIENT'S ROOM TO DELIVER PATIENT CARE. WHEN THEY MOVED THE PILLOW ON THE BED BY THE PATIENT'S LEG, THEY OBSERVED THE BURNT AREA ON THE BED AND PILLOW. THEY POURED WATER ON THE BED TO EXTINGUISH IT. A WARMER LINE OF THE HEATER (PRISMAFLO II DEVICE) ATTACHED TO THE CVVH PRISMA FLEX MACHINE, THAT REWARMS BLOOD ON THE RETURN TO THE PATIENT, CAUSED A SMALL FIRE IN THE MATTRESS AND PILLOW. THE TUBING LINE WAS IN THE PATIENT BED AND WAS FOUND TO BE IN BETWEEN THE PILLOW AND THE MATTRESS AND BEGUN TO BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159149 PRISMAFLO IIS BLOOD WARMER KOC STIHLER ELECTRONIC GMBH PF2-WP33

    Patients

    Seq Age Sex Outcome Treatment
    1