BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 1599164 · Received February 8, 2010

    Report

    Report Number
    1599164
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 8, 2010
    Manufacturer
    GAMBRO RENAL PRODUCTS
    Product Code
    MQS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    GAMBRO PRISMAFLEX SUDDENLY ALARMED AIR DETECTED THEN IT GAVE MESSAGE STOP TREATMENT AND CALL FOR SERVICING. THE RENAL FELLOW WAS CALLED AND RENAL RN OBTAINED REPLACEMENT PRISMAFLEX WHICH WOULD NOT BOOT UP. THERE WAS ONLY A AIR DETECTED WARNING TO CALL SERVICE. A THIRD MACHINE WAS OBTAINED WHICH FUNCTIONED. THE TOTAL TIME THE CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) MACHINE WAS DOWN WAS THREE HOURS AND FORTY-FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX HEMODIALYSIS, CRRT MQS GAMBRO RENAL PRODUCTS * N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR