BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1810376 · Received August 20, 2010

    Report

    Report Number
    1423500-2010-02759
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    May 16, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. BAXTER HAS RECEIVED SIMILAR REPORTS OF PERITONITIS.

    Description of Event or Problem · 1

    INITIALLY, A HOMECHOICE PATIENT (HP) REPORTED A LOW DRAIN VOLUME ALARM TO THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR). TSR HAD THE HP CHECK LINES FOR CLOSED CLAMPS, KINKS, AIR AND FIBRIN. HP INDICATED THERE WAS FIBRIN IN THE LINE AND ADVISED THE PATIENT TO END THERAPY BECAUSE THE FIBRIN WILL CONTINUE TO CAUSE THE MACHINE TO ALARM. DURING A FOLLOW UP CALL (B)(4) 2010 THE NURSE ADVISED, THE FIBRIN WAS CLEARED AND THE PATIENT WAS IN THE HOSPITAL AT THE TIME WITH PERITONITIS DUE TO A COLONOSCOPY. THE NURSE STATED THE PERITONITIS WAS UNRELATED TO TECHNIQUE OR THERAPY. THE PATIENT IS CURRENTLY ON HEMODIALYSIS AND DOING FINE WITH THERAPY. THIS IS THE MASTER COMPLAINT FOR THE EVENT OF PERITONITIS. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY NURSE ON (B)(4) 2010 INDICATES: THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 FOR COMPLAINTS OF WEAKNESS, LOW HEMOGLOBIN AND ELEVATED PROTHOMBIN TIME (PT). ON THAT DATE THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE EFFLUENT WAS CULTURED AND RESULTS WERE NEGATIVE. A CELL COUNT WAS TAKEN BUT THE RESULTS ARE UNKNOWN. A GRAM STAIN WAS TAKEN AND THE RESULTS WERE NEGATIVE. ALL LABS WERE DRAWN ON (B)(6) 2010. THE PATIENT WAS TREATED WITH INTRAVENOUS ZOSYN AND LEVAQUIN (DOSE AND LENGTH OF THERAPY UNKNOWN). THE PATIENT ALSO RECEIVED VANCOMYCIN INTRAPERITONEAL (IP) (DOSE AND LENGTH OF THERAPY UNKNOWN). IT IS UNKNOWN WHAT DATE THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, HOWEVER, THE NURSE INDICATED IT WAS AT THE END OF (B)(6) 2010. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS SEEMED TO BE RELATED TO GASTROINTESTINAL ISSUES THAT THE PATIENT WAS EXPERIENCING AND UNRELATED TO ANY BAXTER PRODUCT OR SOLUTION. NO RETRAINING WAS REQUIRED. THE PATIENT HAS RECOVERED FROM THIS EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 5B4826 DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%?