BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 7406528 · Received April 9, 2018

    Report

    Report Number
    7406528
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 20, 2018
    Report Date
    March 22, 2018
    Manufacturer
    FUTUREMED AMERICA, INC.
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEATER TUBING ON PRISMAFLEX CONSOLE BECAME OVERHEATED. THE RN NOTICED THAT THE GRAY HEATER TUBING FOR THE PATIENT'S PRISMAFLEX SYSTEM WAS GLOWING WHITE. IT LOOKED LIKE THE GRAY HEATER TUBING WAS OVERHEATING. THE NURSE PULLED THE PATIENT'S PRISMAFLEX BLOOD TUBING OUT OF THE GRAY WARMING TUBING AND TURNED THE PRISMAFLEX HEATER "OFF." SHE SAID THE GRAY HEATER TUBING WAS VERY HOT AS SOON AS THE GLOWING WHITE COLOR OUT. THE GRAY TUBING HAD A SMALL (LESS THAN 1 CM DIAMETER) DARK BROWN CIRCLE ON IT WHERE THE APPARENT BURN OCCURRED. THE OUTSIDE OF THE PATIENT'S PRISMAFLEX BLOOD TUBING ALSO WAS SINGED BLACK FROM THE HEAT, BUT DID NOT BURN THROUGH THE TUBING. DISCONTINUED THE PRISMAFLEX THERAPY FOR THIS PATIENT AND NOTIFIED AN ACUTE DIALYSIS NURSE WHO HAPPENED TO THE IN THE UNIT ABOUT THE EVENT. THE DIALYSIS NURSE REMOVED THE HEATER UNIT FROM THE PRISMAFLEX CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250291 PRISMAFLEX WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB FUTUREMED AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR