BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 885888 · Received July 27, 2007

    Report

    Report Number
    3003464075-2007-00163
    Event Type
    Injury
    Date Received
    July 27, 2007
    Date of Event
    June 25, 2007
    Report Date
    June 28, 2007
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY STAFF OBTAINED CULTURES OF THE DIALYSATE, THE SOURCE WATER USED TO MAKE DIALYSATE BATCH, AND THE PURIFICATION PAK USED FOR WATER PURIFICATION. RESULTS OF CULTURE OF THE DIALYSATE AND THE SOURCE WATER WERE BOTH POSITIVE FOR THE SAME BACTERIA, E. CLOACAE, FOUND IN PATIENT'S BLOOD CULTURES. DIALYSATE SAK WAS REQUESTED TO BE RETURNED TO NXSTAGE, BUT HAS NOT BEEN RECEIVED. PURIFICATION PAK WAS RETURNED TO NXSTAGE FOR EVALUATION. INTEGRITY TESTING OF THE TWO ULTRAFILTERS' FIBERS AND HOUSING IN THE PAK PASSED ALL ACCEPTANCE CRITERIA INDICATING THAT PAK FILTERS WERE PERFORMING WITHIN SPECIFICATION FOR REMOVAL OF WATER CONTAMINANTS INCLUDING BACTERIA. THERE HAVE BEEN NO OTHER SIMILAR REPORTS FOR THIS LOT OF DIALYSATE CONCENTRATE. POSITIVE CULTURE OF THE SOURCE WATER AND RESULTS OF PAK INTEGRITY TESTS SUGGESTS THAT THE DIALYSATE SAMPLE WAS MOST LIKELY CONTAMINATED THROUGH TOUCH CONTAMINATION DURING THE SAMPLING PROCESS AND THAT THE RESULTS OF THE DIALYSATE CULTURE MAY BE INVALID. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION OCCURRED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED AT THIS TIME. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 1.5 HOURS INTO A ROUTINE HEMODIALYSIS TREATMENT, PATIENT DEVELOPED TREMORS, HOT/COLD FEELING, SEVERE ABDOMINAL PAIN AND DIARRHEA. TREATMENT WAS DISCONTINUED. PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. PATIENT'S LAB TEST WERE ELEVATED LIVER ENZYMES, AND POTASSIUM 2.7 MMOL/L. PATIENT WAS ADMINISTERED POTASSIUM AND RELEASED. PATIENT SAW THE NEPHROLOGIST LATER THE SAME DAY AND PRESENTED WITH A BLOOD PRESSURE OF 61/43. PATIENT WAS ADMITTED TO THE HOSPITAL AND BLOOD CULTURES DRAWN. BLOOD CULTURES WERE POSITIVE WITH E. CLOACAE. PATIENT RECEIVED ANTIBIOTIC CIPRO IV AND WAS DISCHARGED FROM HOSPITAL IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FII NXSTAGE MEDICAL, INC. SAK-001 FG-070412-04

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other