BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 284538 · Received June 30, 2000

    Report

    Report Number
    8030665-2000-00210
    Event Type
    Injury
    Date Received
    June 30, 2000
    Date of Event
    June 6, 2000
    Report Date
    June 7, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM SEPARATION OCCURRED WITH A VENOUS LINE TO ASH SPLIT CATHETER RESULTING IN A 400CC BLOOD LOSS AND POSSIBLE AIR EMBOLISM. THE EVENT OCCURRED 15-20 MINUTES INTO TREATMENT. THE BAXTER 550 DID NOT ALARM. THE EVENT WAS NOTED AFTER PT INDICATED THAT THEY WERE WET AND BLOOD WAS SEEN ON THE BLUE PAD AND ON THE FLOOR UNDER THE CHAIR. THE PT COMPLAINED OF CHEST PAIN AND ANXIETY. THE PT WAS PLACED IN TRENDELENBERG POSITION AND OXYGEN WAS APPLIED. LINES WERE CLAMPED. ABOUT 4CC OF AIR AND 6CC OF BLOOD WERE ASPIRATED FROM THE VENOUS CATHETER. THE PT WAS TRANSPORTED TO THE ER VIA AMBULANCE. AN ECHOCARDIOGRAM WAS PERFORMED AND NO AIR WAS FOUND PRESENT IN THE HEART AT THE TIME. THE PT WAS KEPT IN THE HOSP OVERNIGHT FOR OBSERVATION. THE PT WAS NOTED TO BE A BRAIN INJURED PT WITH NO IMPULSE CONTROL. PT WAS MOVING AROUND IN THE CHAIR WHILE TRYING TO EAT A CHEESEBURGER. UNSURE IF SAMPLE IS AVAILABLE. QUESTIONNAIRE FAXED ON 6-7-00. 6/9/00 QS LEFT TELEPHONE MESSAGE FOR COMPLAINANT. 6/15/00 QUESTIONNAIRE NOT REC'D BY CUSTOMER, RE-FAXED.

    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 * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O| R