BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA LABORATORIES 7.0 PH SOLUTION

    MDR report key: 3410542 · Received October 2, 2013

    Report

    Report Number
    3410542
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    September 20, 2013
    Report Date
    September 30, 2013
    Manufacturer
    MESA LABORATORIES INC
    Product Code
    FKH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REC'D NOTIFICATION OF POSSIBLE CONTAMINATION OF MESA LABORATORIES 7.0 PH SOLUTION ON (B)(6) /2013. ALL INVENTORY OF THIS SOLUTION WAS REMOVED BY CLINIC MGR FROM CLINICAL AREA AND USE OF PH STRIPS WAS INSTITUTED TO CHECK PH OF DIALYSATE IN DIALYSIS MACHINES UNTIL FURTHER RESOLUTION TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498261 MESA LABORATORIES 7.0 PH SOLUTION PH METER CALIBRATION SOLUTION FKH MESA LABORATORIES INC ML-P7-1148

    Patients

    Seq Age Sex Outcome Treatment
    1