BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1943234 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07466
    Event Type
    Injury
    Date Received
    December 31, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 9, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RETURNED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. A PRODUCT CODE WAS NOT PROVIDED; THEREFORE, NO 510K NUMBER CAN BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED BY BAXTER (B)(4) FROM BAXTER (B)(4) INDICATING A PERITONEAL DIALYSIS PATIENT DEMONSTRATED SIGNS OF PERITONITIS AND CLOUDY DIALYSATE WHEN USING DIANEAL SOLUTION AND PRODUCTS ON AN UNKNOWN DATE. IT IS UNKNOWN IF LAB AND CULTURE TESTS WERE PERFORMED. IT IS UNKNOWN WHAT INTERVENTIONS WERE REQUIRED FOR RESOLUTION OF THE EVENT OF PERITONITIS. NO SAMPLES AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1