BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE FOR FRESENIUS 2008

    MDR report key: 295825 · Received July 18, 2000

    Report

    Report Number
    8030665-2000-00223
    Event Type
    Injury
    Date Received
    July 18, 2000
    Date of Event
    June 23, 2000
    Report Date
    June 29, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PT CONNECTOR DISCONNECT FORM A MEDCOMP DOUBLE LUMEN IJ CATHETER- TO A VENOUS LINE. THE EVENT OCCURRED 2 HOURS INTO TREATMENT. THE PT HAS BEEN ADMINISTERED 2500CC NORMAL SALINE AND PUT IN TRENDENBERG POSITION JUST PRIOR TO THE EVENT. THE STAFF BELIEVE THAT THE MOVEMENT OF THE PT CAUSED THE PROBLEM. ESTIMATED BLOOD LOSS 1500-2000CC. THE PT CODED AT THE CLINIC, WAS RESUSCITATED AND WAS TRANSPORTED TO THE HOSP WHERE HE WAS TRANSFUSED. THE EVENT OCCURRED WITH A 2008H MACHINE WITH NARROW LIMITS SOFTWARE SET TO 20. THE MACHINE DID NOT ALARM. IT WAS NOTED THAT THE "TP" WAS NOT WET. THE BLOOD FLOW RATE WAS 300 ML/MIN. THE VENOUS PRESSURE PREINCIDENT WAS 260 AND AT THE TIME OF THE INCIDENT ROSE TO 320. FOLLOW-UP WITH CLINIC INDICATES THAT THE SAMPLE WAS DISCARDED. AWAIT USER FACILITY REPORT. QUESTIONAIRE RECEIVED 07/07/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRESENIUS 2008 BLOODLINE TUBING FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R 1. 2008H WITH NARROW LIMITS SOFTWARE| 2. MEDCOMP DOUBLE LUMEN IJ SL20 CATHETER.