BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX CO2 ACID REAGENT

    MDR report key: 2435483 · Received February 1, 2012

    Report

    Report Number
    2050012-2012-00357
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EVALUATED BY MANUFACTURER BECAUSE THE PRODUCT WAS DISCARDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012 CUSTOMER REPORTED THAT THEY RECEIVED A BOX OF CO2 ACID CONTAINERS THAT HAD LEAKED. CUSTOMER DID NOT DETERMINE THE CAUSE OF THE LEAK. NO INJURIES OR EXPOSURE WERE REPORTED. A REPLACEMENT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX CO2 ACID REAGENT PH RATE MEASUREMENT, CARBON-DIOXIDE CKA BECKMAN COULTER, INC. 107156

    Patients

    Seq Age Sex Outcome Treatment
    1