BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLO IIS

    MDR report key: 8554079 · Received April 26, 2019

    Report

    Report Number
    9617473-2019-00002
    Event Type
    Malfunction
    Date Received
    April 26, 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

    THE HEATING DEVICE (WARMING TUBING), WHICH WAS DESCRIBED IN THE EVENT DESCRIPTION, IS NOT A PART OF THE PRISMAFLEX DIALYSIS SYSTEM MANUFACTURED BY BAXTER. THIS DEVICE IS A BLOOD WARMER PRISMAFLO IIS MANUFACTURED BY STIHLER ELECTRONIC AS AN ACCESSORY TO PRISMAFLEX DIALYSIS SYSTEM. IT IS INTENDED TO WARM THE BLOOD RETURN LINE DURING PRISMAFLEX CRRT TREATMENT. BECAUSE OF THE CHARACTERISTICS OF THIS EVENT THE MANUFACTURER JUDGES THE EVENT FITS IN THE RECALL FOR THIS PRODUCT THAT ADDRESSES THIS POTENTIAL FAILURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE NOTICED THE RETURN TUBE WAS EXTREMELY HOT. UPON INSPECTION THE NURSE FOUND A HOLE BURNED IN THE WARMING TUBING AND A BURN MARK ON THE RETURN LINE. THE NURSE STOPPED THE CONTINOUS RENAL REPLACEMENT THERAPY (CRRT). THE NURSE NOTIFIED THE DIALYSIS NURSE. THE PRISMAFLEX WAS SWITCHED OUT WITH ANOTHER PRISMAFLEX. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351811 PRISMAFLO IIS BLOOD WARMER KOC STIHLER ELECTRONIC GMBH PF2-WP33

    Patients

    Seq Age Sex Outcome Treatment
    1