BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 456090 · Received April 22, 2003

    Report

    Report Number
    1721979-2003-00001
    Event Type
    Other
    Date Received
    April 22, 2003
    Date of Event
    April 16, 2003
    Report Date
    April 21, 2003
    Manufacturer
    HEMAMETRICS
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 50 MINUTES INTO DIALYSIS TREATMENT, ATTENDANT NOTED BLOOD DRIPPING FROM TUBING AND ONTO THE FLOOR. IT WAS DETERMINED THAT THE BLOOD SOURCE WAS AT OR NEAR THE HEMA METRICS CRIT-LINE BLOOD CHAMBER. THE TREATMENT WAS STOPPED, THE CRIT-LINE BLOOD CHAMBER REPLACED, THE TUBING SET ADAPTOR RECONNECTED AND TIGHTENED AND THE PROCEDURE RESTARTED. THE BLOOD LOSS WAS ESTIMATED AT 100-150ML. THE DURATION OF THE BLOOD LOSS WAS NOT KNOWN BUT HAVE BEEN AS LONG AS 20-25 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRIT-LINE BLOOD CHAMBER STERILE, SINGLE USE, DIALYSIS ACCESS KOC HEMAMETRICS 10021021 020703(LAST LOT SHIPPED)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other