BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE FOR FRESENIUS 2008

    MDR report key: 291299 · Received August 18, 2000

    Report

    Report Number
    8030665-2000-00246
    Event Type
    Injury
    Date Received
    August 18, 2000
    Date of Event
    July 17, 2000
    Report Date
    August 18, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DSD CQM REPORTS THAT 90 MINUTES INTO TREATMENT THE VENOUS LINE BECAME DISCONNECTED FROM THE ASH SPLIT CATHETER RESULTING IN ABOUT A 200CC BLOOD LOSS TO THE PT. PT IS A PYSCHIATRIC PT AND WAS THOUGHT TO HAVE PULLED THE LINE OUT. THE USE OF RESTRAINTS FOR FURTHER TREATMENTS WAS DISCUSSED. THE SAMPLE WAS SAVED HOWEVER, FOR ANALYSIS. THE PT WHO NORMALLY HAS HIGH BLOOD PRESSURE EXPERIENCED A DROP IN BLOOD PRESSURE AND 500 ML OF SALINE WAS ADMINISTERED. TREATMENT WAS INITIATED WITH A NEW LINE AND WAS COMPLETED WITHOUT INCIDENT. THE PT EXPERIENCED NO FURTHER SYMPTOMS AND WAS DISCHARGED FROM THE UNIT IN STABLE CONDITION. THE 20008H WITH NVL SOFTWARE SET TO 20, DID ALARM. THE BLOOD FLOW RATE DURING TREATMENT WAS 350ML/MIN AND THE VENOUS PRESSURE PRE INCIDENT WAS 120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRESENIUS 2008 BLOODLINE TUBING FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA 9HR051

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 2008H WITH NVL SOFTWARE, ASHSPLIT CATHETER.