BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA LABORATORIES 7.0 PH SOLUTION

    MDR report key: 3670470 · Received October 3, 2013

    Report

    Report Number
    3670470
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    September 25, 2013
    Report Date
    October 2, 2013
    Manufacturer
    MESA LABORATORIES
    Product Code
    FKH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A 7.0 PH SOLUTION FROM (B)(4) RECALLED. THIS SOLUTION IS USED TO CALIBRATE PHOENIX METERS WHICH ARE USED TO TEST PH AND CONDUCTIVITY ON OUR DIALYSIS MACHINES. FIRST ALERT SENT OUT FROM MESA LABORATORIES ON (B)(6) INDICATING 'BACTERIA GROWTH' IN 7.0 PH SOLUTION. ALERT INFORMS US TO SEQUESTER ALL AFFECTED BOTTLES OF 7.0 PH SOLUTIONS. SOLUTION SEQUESTERED ON (B)(6) 2013. ALL DIALYSIS MACHINES HEAT OR BLEACH DISINFECTED PER THE FIRST ALERT. SECOND ALERT SENT OUT ON (B)(6). THIS ALERT CHANGES TERMINOLOGY FROM 'BACTERIA GROWTH' TO 'MOLD.' ALERT INFORMS US TO PERFORM BLEACH DISINFECTION ON ALL DIALYSIS MACHINES. MACHINES DISINFECTED PER THE ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502006 MESA LABORATORIES 7.0 PH SOLUTION MESA LABORATORIES 7.0 PH SOLUTION FKH MESA LABORATORIES ML-P7-1148

    Patients

    Seq Age Sex Outcome Treatment
    1