BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APO SET W/CASSETTE3-PRONG

    MDR report key: 1160484 · Received September 12, 2008

    Report

    Report Number
    1423500-2008-00795
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    IN 2008, A NURSE CONTACTED BAXTER'S TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM DURING A PREVIOUS NIGHT'S THERAPY WHILE USING THE HOME CHOICE SYSTEM. THE TSR ADVISED THE HP TO USE NEW SUPPLIES FOR THAT NIGHT'S THERAPY. THE HOME PATIENT (HP) ABANDONED THERAPY FOR THAT NIGHT. THE NURSE WAS CALLING TO UNDERSTAND THE MEANING OF THE 2240 ALARM. THE TSR EXPLAINED COMMON CAUSES OF THE ALARM AND SOME POSSIBILITIES OF AIR BEING INTRODUCED TO THE CASSETTE. ON ELEVEN DAYS LATER, THE PERITONEAL DIALYSIS (PD) NURSE STATED THAT THE ALARM WAS MOST LIKELY THE RESULT OF THE PATIENT'S POOR VISION AND POOR LIGHTING IN THE PATIENT'S ROOM AT THE NURSING HOME (WHERE HE WAS STAYING FOR A BROKEN LEG), RESULTING IN A BREAK IN ASEPTIC TECHNIQUE LEADING TO THE 2240 ALARM AND PERITONITIS. THE PATIENT WAS RETRAINED ON PROPER PROCEDURE. THE PATIENT WAS DIAGNOSED WITH THE PERITONITIS ON FIVE DAYS AFTER THE ORIGINAL DATE, AND HOSPITALIZED ON FIVE DAYS LATER, BECAUSE THE PERITONITIS WAS NOT IMPROVING. THE HP STILL HAD ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON THE FOLLOWING MONTH, A FOLLOW UP CALL TO THE PD NURSE REVEALED THAT AFTER 2 WEEKS OF ANTIBIOTIC THERAPY, THE PATIENT DID NOT RECOVER. THE HP'S CATHETER WAS REMOVED AND THE HOME PATIENT WAS PUT ON HEMODIALYSIS. THE HP IS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APO SET W/CASSETTE3-PRONG 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R