BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1848876 · Received September 30, 2010

    Report

    Report Number
    1423500-2010-03929
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 6, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE PRODUCT CODE IS UNKNOWN AND THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION WAS PERFORMED. AS THE PRODUCT CODE IS UNKNOWN, THE 510K NUMBER CANNOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TUBING LEAKING LYSE ON THE COULTER LH 750 ANALYZER. THE OPERATOR WAS USING PROPER PPE WHEN THE TUBING LEAK WAS DISCOVERED. NO EXPOSURE OF THE LYSE REAGENT TO MUCOUS MEMBRANES OR OPEN LESIONS AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE (B)(6) FEVER AND PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY AND DUE PATIENT SCRATCHING AT THE EXIT SITE AND DID NOT WEAR A MASK DURING THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 UNKNOWN BAG INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY FIBRIN, PINEAPPLE-LIKE EFFLUENT, AND FEVER. ON (B)(6)2010 THROUGH (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. REMEDIAL THERAPY WAS STARTED WITH CEFAZOLIN 10MG, INTRAVENOUS (IV) FOR AN UNKNOWN LENGTH OF THERAPY. IT IS UNKNOWN IF THE DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE PERITONITIS IS IMPROVED. IT WAS UNKNOWN IF THE FEVER RESOLVED. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY, BUT WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE BREAK IN ASEPTIC TECHNIQUE OR THE FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG