BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 287405 · Received July 24, 2000

    Report

    Report Number
    8030665-2000-00236
    Event Type
    Injury
    Date Received
    July 24, 2000
    Date of Event
    June 29, 2000
    Report Date
    July 11, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FMC CLINICAL QUALITY MGR CALLED QUALITY SERVICE TO NOTIFY CO OF THIS PT DISCONNECT, VENOUS BLOODLINE FROM TESIO CATHETER. THE REPORTED DISCONNECT WAS FOUND AT ONE HOUR AND FIFTEEN MINUTES INTO TREATMENT. THE 2008H MACHINE WITH NVL SOFTWARE DID ALARM. PT LOST 400-500CC BLOOD VOLUME FROM THE DISCONNECTION. ALSO REPORTED THAT PT LOST CONSCIOUSNESS. MEDICAL INTERVENTION INCLUDED HOSPITALIZATION AND LATER TRANSFUSION OF TWO UNITS OF PACKED CELLS. PT CURRENTLY STABLE. MDR FILED DUE TO BLOOD LOSS, HOSPITALIZATION. 07/11/2000 QUALITY SERVICE CALLED FACILITY TO VERIFY INFO. TELEPHONE MESSAGE LEFT 07/14/2000 NOTIFIED THAT NURSING DIR WILL FORWARD A COPY OF USER FACILITY REPORT. 07/17/2000 MDR USER FACILITY REPORT REC'D.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O TESIO CATHETER IMPLANTED. 1999| FRESENIUS 2008H W/NVL SOFTWARE,