BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008K HEMODIALYSIS MACHINE

    MDR report key: 3135525 · Received April 23, 2013

    Report

    Report Number
    3135525
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 18, 2013
    Manufacturer
    FRESENIUS USA
    Product Code
    KDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT MOVED HIS ARM DURING TREATMENT AND VENOUS NEEDLE GOT DISLODGED. HEMODIALYSIS MACHINE DID NOT ALARM AND VENOUS PRESSURE LIMITS WERE NOTED AT 160. TREATMENT INTERRUPTED, BLOOD PUMP STOPPED, VENOUS LINE CLAMPED AND PRESSURE APPLIED ON THE NEEDLE EXIT SITE. BLOOD RETURNED VIA ARTERIAL NEEDLE. BLOOD LOST APPROXIMATELY 250ML TO 300ML. PATIENT WAS ALERT AND RESPONSIVE, COMPLAINING OF NAUSEA, VOMITING AND SHORTNESS OF BREATH. PATIENT REPLACED WITH 700ML OF IV FLUIDS AND FIRE RESCUED CALLED. PATIENT ALERT AT THE TIME FIRE RESCUE ARRIVED, RECEIVING O2 PER NASAL CANULA AND SENT TO THE HOSPITAL FOR FURTHER EVALUATION. DR (B)(6) NOTIFIED PATIENT WAS ADMITTED TO THE HOSPITAL AND KEPT FOR ONE DAY RETURNING TO OUR FACILITY FOR THE NEXT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175879 FRESENIUS 2008K HEMODIALYSIS MACHINE HEMODIALYSIS MACHINE KDI FRESENIUS USA FRESENIUS 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization