BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1048929 · Received May 20, 2008

    Report

    Report Number
    1721979-2008-00001
    Event Type
    Other
    Date Received
    May 20, 2008
    Manufacturer
    HEMA METRICS, INC.
    Product Code
    KOC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DESCRIPTION GIVEN BY USER FACILITY, IT APPEARS THAT THE FACILITY DID NOT ADHERE TO THE INSTRUCTIONS PROVIDED WITH BLOOD CHAMBER REQUIRING TECHNICIANS TO CHECK THE BLOOD CHAMBER CONNECTIONS THROUGHOUT THE DIALYSIS TREATMENT. REP WAS CONTACTED CONCERNING THE INCIDENCE. WE DISCUSSED THE PROPER WAY TO CONNECT BLOOD CHAMBERS TO DIALYSIS BLOOD LINES AND THE DIALYZER. AN EMAIL WAS SENT ON MAY 5, 2008 AT REQUEST REITERATING THE INSTRUCTIONS GIVEN OVER THE PHONE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED AN EVENT WHERE DURING DIALYSIS TREATMENT, THE BLOOD CHAMBER (ADAPTER) HAD COME LOOSE. THE ADAPTER HAD BEEN TIGHTENED PRIOR TO USE. IT WAS REPORTED THAT NO ELECTROPHYSIOLOGY PROCEDURE WAS DONE OR ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KOC HEMA METRICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1