BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F70 HEMOFLOW DIALYZER 12/CS

    MDR report key: 219707 · Received April 14, 1999

    Report

    Report Number
    1713747-1999-00125
    Event Type
    Injury
    Date Received
    April 14, 1999
    Date of Event
    February 20, 1999
    Report Date
    April 2, 1999
    Manufacturer
    FRESENIUS
    Product Code
    KJI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTING AN INCREASE IN BLOOD LEAKS SINCE FEBRUARY, WHEN THE FACILITY BEGAN USING F70NR DIALYZER. THIS IS THE REPORT OF THE FIRST OF FIVE INTERNAL BLOOD LEAKS. THERE WERE TWO LOT NUMBERS IDENTIFIED AMONG THE FIVE COMPLAINTS. THE PT WAS INITIATED ONTO DIALYSIS WITH THE COBEC3 DIALYSIS MACHINE. TWO MINUTES LATER, BLOOD WAS SEEN AND DETECTED IN THE DIALYSATE EFFLUENT. GROSS BLOOD WAS EVIDENT. ACCORIDNG TO HEALTH CARE PROFESSIONAL, NOT ABLE TO REINFUSE BLOOD, SYSTEM OF APPROXIMATELY 210 CC DISCARDED. NO PT (MEDICAL) INTERVENTION NECESSARY. COMPLAINT SAMPLE WAS DISCARDED. REQUESTED THAT ANY FUTURE SAMPLES BE SAVED AND TO NOTIFY QUALITY SYSTEMS. MDR FILED DUE TO BLOOD LOSS REPORTED. UNABLE TO ACQUIRE FURTHER INFO REGARDING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F70 HEMOFLOW DIALYZER 12/CS SINGLE USE HIGH FLUX DIALYZER KJI FRESENIUS NA 8N10208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 2/20/99 HEMODIALYSIS TREATMENT/NON-REUSE.