BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DICEA DIALYZER

    MDR report key: 305467 · Received November 14, 2000

    Report

    Report Number
    1423500-2000-01159
    Event Type
    Malfunction
    Date Received
    November 14, 2000
    Date of Event
    October 7, 2000
    Report Date
    October 16, 2000
    Manufacturer
    NISSHO CORP
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER AFFILIATE REPORTS TWO INCIDENTS OF CLOTTED DIALYZERS DURING PT TREATMENT. THESE OCCURRED ON NEW DRY-PACK DIALYZERS. NOTED BY A VENOUS AND ARTERIAL PRESSURE ALARM. DIALYZERS CLOTTED AND THEN BURST DUE TO A BUILD-UP OF AIR. NO PT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DICEA DIALYZER HOLLOW FIBER DIALYZER KDI NISSHO CORP DCA 170G E00B28

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN