BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 276063 · Received April 28, 2000

    Report

    Report Number
    8030665-2000-00144
    Event Type
    Malfunction
    Date Received
    April 28, 2000
    Date of Event
    April 11, 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
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS THAT A DISCONNECT EVENT OCCURRED ON 4-11-00. THE VENOUS LINE DISCONNECTED FROM THE TESIO CATHETER. THE CATHETER WAS IMPLANTED IN 2000. THE ESTIMATED BLOOD LOSS 100-200CC. LINE WAS RECONNETED TO THE CATHETER AND TREATMENT RESUMED WITHOUT FURTHER INCIDENT THE SAMPLE WAS DISCARDED. THE BAXTER MACHINE DID NOT ALARM. PT SUFFERED NO ILL EFFECTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other TESIO CATETER, BAXTER 550, F80B DIALYZER.