BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLO II S

    MDR report key: 10527504 · Received September 14, 2020

    Report

    Report Number
    10527504
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    July 17, 2020
    Report Date
    July 20, 2020
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    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
    995867 PRISMAFLO II S ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS KOC STIHLER ELECTRONIC GMBH PF2300NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5110 DA