BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 218387 · Received March 25, 1999

    Report

    Report Number
    8030665-1999-00088
    Event Type
    Malfunction
    Date Received
    March 25, 1999
    Date of Event
    March 10, 1999
    Report Date
    March 12, 1999
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTICE OF COMPLAINT ABOVE PRODUCT VIA PHONE CALL FORM FACILITY DIRECTOR OF NURSING. REPORTS AN EVENT IN WHICH THE MONITOR LINE SEPARATED FROM THE VENOUS DRIP CHAMBER DURING A PATIENT TREATMENT. THE SEPARATION OCCURRED APPROXIMATELY 1/2 WAY THROUGH THE TREATMENT. THE DON REPORTS THAT THE HEALTH CARE PROFESSIONAL WAS AT THE MACHINE WHEN THE SEPARATION OCCURRED AND NOTED IT IMMEDIATELY. THE BLOOD LOSS WAS REPORTED AS 500CC. THE PATIENT WAS STABLE AND DID NOT REQUIRE AND MEDICAL INTERVENTION. THE LINE IS AVAILABLE FOR EVAUALTION. A RESPONSE LETTER AND MAILER HAVE BEEN SENT TO THE FACILITY. A MEDWATCH FORM HAS BEEN FILED BASED ON REPORTED BLOOD LOSS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE FOR HEMODIALYSIS FJK ERIKA DE REYNOSA NA R8N108

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other FRESENIUS 2008H HEMODIALYSIS MACHINE.