BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERICHEK TOTAL CHLORAMINE AND RESIDUAL CHLORINE

    MDR report key: 1153743 · Received September 3, 2008

    Report

    Report Number
    1153743
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 14, 2008
    Report Date
    September 2, 2008
    Manufacturer
    HACH COMPANY
    Product Code
    MSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MACHINE IN USE SEVERAL TIMES. WAS CLEANED/REVISED AND TEST FOR BLEACH SHOWED. ON 7/14 PATIENT CONDITION WORSENED WITHIN 10 MINUTES OF START OF DIALYSIS. AFTER RINSEBACK BLOOD LINE TURNED LIGHT BROWN. DRAIN LINE NEGATIVE FOR BLEACH; BLUE HANSON CONNECTOR AND I PRESSURE BLEACH. PATIENT TO ED THEN TCN FOR DIALYSIS, AND OVERNIGHT STAY. OUR FACILITY NOTIFIED OF HACH REAGENT STRIP RECALL ON 7/24 VIA A RENAL NETWORK. FALSE NEGATIVES AND POSITIVES BEING FOUND, THE REPORT SHOWS. NOT CLEAR WHAT CAUSE OF PATIENT'S CHANGE IN CONDITION. REAGENT STRIPS FAULTY. HOWEVER BLEACH EXPOSURE IS AMONG THE POSSIBILITIES. INCREASED LENGTH OF TUBING TO RINSE ALSO. DIALYSIS EQUIPMENT MANUFACTURERS NOTIFIED OF INCIDENT AND RESPONDED (FRESENIUS) CONNECTOR IS TWO STEP TO CLICK/SNAP. ALSO, POTENTIAL FOR BLEACH TO ACCUMULATE DURING "LAST PEDOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERICHEK TOTAL CHLORAMINE AND RESIDUAL CHLORINE REAGENT STRIPS MSY HACH COMPANY 811909
    2 ASSOCIATED EQUIPMENT FRESENIUS DIALYSIS EQUIPMENT FII FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other