BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1550 HEMODIALYSIS MACHINE

    MDR report key: 1230762 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-00089
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    January 20, 2007
    Report Date
    January 22, 2007
    Manufacturer
    LARGO
    Product Code
    KDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO BAXTER THAT THREE PATIENTS PRESENTED THE SAME SYMPTOMS, FEVER AND CHILLS DURING USE OF THIS PARTICULAR INSTRUMENT. IT WAS ALSO REPORTED THAT AFTER THE THIRD INCIDENT, THE FACILITY'S BIOMEDICAL TECHNICIAN REMOVED THE INSTRUMENT FROM SERVICE AND COLLECTED A SAMPLE FOR COLONY COUNT. THE SAMPLE WAS SENT TO INDEPENDENT EXTERNAL LABORATORY FOR TESTING IN 2007. AT ABOUT 3 DAYS LATER, THE RESULTS FROM THE TESTING ARRIVED NEGATIVE, (COLONY COUNT FOR 24 HOURS, LESS THAT 2 CFU/ML). A NURSE FORM THE CLINIC, INFORMED THE BAXTER SERVICE TECHNICIAN THAT THE RESULTS FROM THE BLOOD CULTURE WERE NEGATIVE. FINALLY THE INSTRUMENT WAS PLACED BACK INTO SERVICE, AFTER WAS DISINFECTED ACCORDING TO 1550 INSTRUMENT SERVICE MANUAL. BAXTER IS MONITORING ISSUES LIKE THIS. IF ADDITIONAL INFORMATION IS DISCOVERED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER AFFILIATE REPORTED AN INCIDENT THAT OCCURRED. A PATIENT DIAGNOSED WITH END STAGE RENAL DISEASE, EXPERIENCED AN UNUSUAL EVENT DURING A REGULAR HEMODIALYSIS TREATMENT. APPROXIMATELY 30 MINUTES INTO THE TREATMENT, THE PATIENT STARTED COMPLAINING OF CHEST PAIN AND DEVELOPED FEVER AND CHILLS. PER THE FACILITY PROTOCOL, A BLOOD CULTURE WAS COLLECTED AND THE PATIENT SENT TO THE EMERGENCY ROOM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE NEXT DAY AND HAD A SUBSEQUENT TREATMENT AT THE DIALYSIS CLINIC WITH NO FURTHER CLINICAL CONSEQUENCES. THE PATIENT WAS DIALYZED VIA AV FISTULA. IT WAS, ALSO, REPORTED THAT THIS PATIENT HAS A PACEMAKER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1550 HEMODIALYSIS MACHINE HEMODIALYSIS SINGLE PATIENT SYSTEM, 1550 KDI LARGO 5M5538 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization