BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX M100 SET

    MDR report key: 6176292 · Received December 15, 2016

    Report

    Report Number
    8010182-2016-00094
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    September 4, 2016
    Report Date
    December 14, 2016
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). THE VASCULAR ACCESS CATHETER WAS IN THE INTERNAL JUGULAR VEIN. REPORTEDLY, THE PATIENT WAS CONFUSED AND VERY RESTLESS, CONTINUOUSLY MOVING HIS HEAD AROUND WHICH WAS CAUSING TENSION ON THE LINES. THE NURSE AT THE BEDSIDE NOTED THE RETURN PORT HAD BECOME DISCONNECTED FROM THE VASCULAR ACCESS CATHETER RESULTING IN AN ESTIMATED BLOOD LOSS OF 100 - 150 ML. THE PATIENT WENT INTO A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST REQUIRING SIX MINUTES OF CPR AND BLOOD PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826865 PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES PRISMAFLEX M 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRISMAFLEX (SN: UNKNOWN)