BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX M150

    MDR report key: 3781934 · Received April 30, 2014

    Report

    Report Number
    8010182-2014-00017
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K080519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FILES RELATED TO THE USED PRISMAFLEX M150 SETS COULD NOT BE CHECKED AS THE LOT NUMBER IS UNKNOWN. THE USED PRISMAFLEX SETS WERE DISCARDED AFTER THE EVENT AND NO FURTHER INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT HAD AN ESTIMATED BLOOD LOSS OF 567ML WHEN THE CONTENT OF THREE EXTRACORPOREAL CIRCUITS WAS NOT RETURNED AS A RESULT OF CLOTTED FILTERS. ACCORDING TO THE DIALYSIS RN, THERE WERE ISSUES WITH THE ACCESS CATHETER WHICH LEAD TO THE FILTER CLOTTING. THE PATIENT DID RECEIVE BLOOD TRANSFUSIONS FOLLOWING THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259377 PRISMAFLEX M150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 109990 UNKNOWN

    Patients

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