BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 275734 · Received April 24, 2000

    Report

    Report Number
    8030665-2000-00141
    Event Type
    Malfunction
    Date Received
    April 24, 2000
    Date of Event
    April 14, 2000
    Report Date
    April 18, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR REPORTS THAT A DISCONNECT EVENT OCCURRED ON 04/14/2000. THE VENOUS LINE DISCONNECTED FROM THE SCHON CATHETER. THE CATHETER WAS IMPLANTED IN 1999. THE EVENT OCCURRED 1 1/2 HRS INTO TREATMENT. THE ESTIMATED BLOOD LOSS <100CC. THE SAMPLE WAS DISCARDED. LOW VENOUS PRESSURE ALARMED. EPO WAS ADMINISTERED INTO THE LINE JUST BEFORE THE EVENT BUT THIS DID NOT SEEM TO INVOLVE MOVING OF THE LINE. NO PT ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE FKJ ERIKA DE REYNOSA * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other SCHON CATHETER.