BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABL800 FLEX

    MDR report key: 3952780 · Received July 10, 2014

    Report

    Report Number
    1523456-2014-00003
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 12, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DUE TO A PROBLEM WITH A LEAKAGE FROM THE ABL820 INLET THE CUSTOMER DECIDED TO PERFORM A PROTEIN REMOVAL WITH A STANDARD HYPOCHLORITE SOLUTION. ACCORDING TO THE OPERATOR MANUAL (P. 7-21) THE PROTEIN REMOVAL PROGRAM SHOULD BE SELECTED ON THE ANALYZER, AND THEN A SYRINGE CONTAINING 0.5ML HYPOCHLORITE SOLUTION SHOULD BE PLACED IN THE INLET. THE USER MUST THEN PRESS START AND THE ANALYZER WILL RUN THE PROGRAM. IN THIS CASE THE USER TRIED TO INJECT THE HYPOCHLORITE SOLUTION INTO THE INLET, AND SINCE NO PUMPS WERE RUNNING AS THE PROGRAM WAS NOT STARTED, THE HYPOCHLORITE WAS SPRAYED IN HIS FACE. THE USER DID NOT WEAR EYE PROTECTION AND HE THEREFORE GOT HYPOCHLORITE IN HIS EYE. THE AFFECTED USER FLUSHED HIS EYE FOR 15 MINUTES AND REPORTED TO EMERGENCY ROOM WHERE HE WAS CHECKED AND RELEASED. HE HAS AFTERWARDS STATED THAT HE IS DOING FINE. REF MFR# 3002807968-2014-00020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405033 ABL800 FLEX ABL820 CHL RADIOMETER MEDICAL APS ABL820

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention