BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 294839 · Received August 25, 2000

    Report

    Report Number
    8030665-2000-00263
    Event Type
    Malfunction
    Date Received
    August 25, 2000
    Date of Event
    August 1, 2000
    Report Date
    August 25, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS A PT CONNECTOR DISCONNECTED FROM A TESIO CATHETER. THE 2008H WITH "NVL" SOFTWARE DID NOT ALARM. THE SAMPLE IS AVAILABLE FOR EXAMINATION. THE PT WAS FOUND WITH HAND WRAPPED AROUND THE LINE AND IS THOUGHT TO HAVE PULLED IT APART FROM THE CATHETER CONNECTION. ESTIMATED BLOOD LOSS 100CC. NO PT ILL EFFECTS. NO MEDICAL INTERVENTION. THE BLOOD FLOW RATE WAS 400 AND THE "VP" PRE INCIDENT WAS 280. THE EVENT OCCURRED 3 HOURS AND 35 MINUTES INTO THE TREATMENT. MEDWATCH FILED DUE TO BLOOD LOSS ONLY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other TESIO CATHETER, 20008H, WITH NVL SOFTWARE,8/1/2000