BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 294531 · Received August 28, 2000

    Report

    Report Number
    8030665-2000-00254
    Event Type
    Injury
    Date Received
    August 28, 2000
    Date of Event
    August 3, 2000
    Report Date
    August 28, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT THE MED PORT SEPARATED FROM THE VENOUS DRIP CHAMBER. PT LOST APPROXIMATELY 200CC OF BLOOD. NO ADDITIONAL ILL EFFECTS. NO MEDICAL INTERVENTION. SAMPLE IS AVAILABLE FOR EXAMINATION. BLOOD FLOW RATE 450ML/MIN. "VP" PRE INCIDENT 280, POST 260-400 MEDWATCH FILED ON THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE TUBING FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA 0ER135

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 2008H.