BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLO® II S

    MDR report key: 8054562 · Received November 9, 2018

    Report

    Report Number
    8054562
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 5, 2018
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS ON CONTINUOUS RENAL REPLACEMENT THERAPIES (CRRT), THE BLOOD WARMER COIL STARTED SMOKING AND BURNT THROUGH THE ACCESS BLOOD TUBING. THE REGISTERED NURSE IMMEDIATELY TURNED OFF THE CRRT MACHINE AND DISCONNECTED IT FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT MANUFACTURER RESPONSE FOR BLOOD WARMER, GAMBRO (PER SITE REPORTER). THERE IS A RECALL FOR THIS PRODUCT THAT ADDRESSES THIS POTENTIAL FAILURE. MANUFACTURER WILL OFFER REMEDIATION OF SUCH RECALL FOR ALL IMPACTED DEVICES FREE OF CHARGE. PRIOR LETTER OF RECALL NEVER MADE IT TO OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895139 PRISMAFLO® II S ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS KOC STIHLER ELECTRONIC GMBH PF2300NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA