BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARTRIDGE

    MDR report key: 4562084 · Received March 2, 2015

    Report

    Report Number
    2087532-2015-00015
    Event Type
    Death
    Date Received
    March 2, 2015
    Date of Event
    January 29, 2015
    Report Date
    February 27, 2015
    Manufacturer
    GAMBRO RENAL PRODUCTS S. A. DE C. V.
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CHRONIC DIALYSIS PT WITH END STAGE RENAL DISEASE WAS ADMITTED TO THE EMERGENCY ROOM WITH CHEST PAIN. ACCORDING TO THE NURSE MANAGER THE PT HAD MISSED A PREVIOUSLY SCHEDULED DIALYSIS TREATMENT. THE PT WAS SENT TO THE HOSPITALS' INPATIENT DIALYSIS UNIT FOR A DIALYSIS TREATMENT. WHEN HE ARRIVED ON THE UNIT, HE WAS AWAKE, ALERT, AND ORIENTED WITH STABLE VITAL SIGNS. DURING THE DIALYSIS TREATMENT, THE PT HAD A CARDIAC ARRHYTHMIA, A RUN OF VENTRICULAR TACHYCARDIA AND HE BECAME UNRESPONSIVE. THE DIALYSIS TREATMENT WAS STOPPED AND RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PT EXPIRED. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST. THE NURSE MANAGER STATED THERE WERE NOT ANY CONCERNS WITH THE EQUIPMENT AND THE DIALYSIS TREATMENT HAD BEEN UNEVENTFUL UNTIL THE CARDIAC ARREST. MFR REF # 8030638-2015-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142592 CARTRIDGE FJK GAMBRO RENAL PRODUCTS S. A. DE C. V. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death