BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX ST150

    MDR report key: 9466355 · Received December 13, 2019

    Report

    Report Number
    8010182-2019-00212
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    October 31, 2019
    Report Date
    January 24, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS A PRISMAFLEX SET SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT WITH A PRISMAFLEX MACHINE AND A PRISMAFLEX SET A 'HIGH RETURN PRESSURE' ALARM WAS TRIGGERED WHEN THE PATIENT ROLLED TO THEIR SIDE. THE RETURN LINE WAS NOTED TO BE KINKED. THE PROBLEM WAS RESOLVED AND THE MACHINE WAS RESTARTED. IT WAS REPORTED THE PATIENT WHILE ATTEMPTING TO SIT UP FOR APPROXIMATELY THREE TO FOUR MINUTES BECAME HYPOTENSIVE. THE RETURN BLOOD LINE WAS NOTED TO BE DISCONNECTED FROM THE PATIENT¿S FEMORAL VASCATH. THE ESTIMATED BLOOD LOSS WAS 250-560 ML. CRRT TREATMENT WAS STOPPED, AND UNKNOWN MEDICAL INTERVENTION AND EMERGENCY CARE WAS ADMINISTERED. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262445 PRISMAFLEX ST150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRISMAFLEX MACHINE