BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1896983 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05640
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 20, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IN (B)(6) 2010, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. THE NURSE CONTACTED BAXTER'S TECHNICAL SERVICE (BTS) CENTER REGARDING A LOW DRAIN VOLUME ALARM THAT OCCURRED DURING THE INITIAL DRAIN ON THE HOMECHOICE (HC) MACHINE. DURING FOLLOW UP WITH THE NURSE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 FOR PERITONITIS. ON THIS SAME DAY, PRIOR TO INITIATING ANTIBIOTIC THERAPY, A SAMPLE OF PERITONEAL EFFLUENT WAS ANALYZED, CULTURED, AND A GRAM STAIN WAS PERFORMED. THE CULTURE RESULTS WERE NEGATIVE; THE GRAM STAIN REVEALED NO ORGANISM AND THE RESULT OF THE CELL COUNT, INCLUDING LEUCOCYTES (WHITE BLOOD CELLS) WAS UNKNOWN. THE PATIENT WAS DIAGNOSED WITH ASEPTIC PERITONITIS AND BEGAN ANTIBIOTIC THERAPY (TYPE, DOSE, FREQUENCY OR ROUTE NOT REPORTED). ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT'S DISCHARGE DIAGNOSIS INCLUDED DIVERTICULITIS, WHICH WAS CONSIDERED PART OF THE PATIENT'S MEDICAL HISTORY. THE ROOT CAUSE OF THE ASEPTIC PERITONITIS WAS DIVERTICULITIS. THERE WAS NO BREAK IN ASEPTIC TECHNIQUE, AND NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE ASEPTIC PERITONITIS. THE COURSE OF ANTIBIOTIC THERAPY LASTED A TOTAL OF THREE WEEKS. THE EVENT OF ASEPTIC PERITONITIS WAS CONSIDERED RESOLVED AFTER COMPLETION OF ANTIBIOTIC THERAPY. PD THERAPY CONTINUED. THE NURSE BELIEVED THAT THE EVENT OF ASEPTIC PERITONITIS WAS UNRELATED TO PD THERAPY. THE NURSE SUSPECTED THAT THE PATIENT DEVELOPED THE ASEPTIC PERITONITIS DUE TO THE DIVERTICULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 LISINOPRIL, NEXIUM, LIPITOR, COLACE, GLUCOSAMINE| LEVOTHYROXINE, ALLOPURINOL, DUCOLAX, DIANEAL UNK| RENVELA, FOLIC ACID, IMDUR, TENORMIN, LASIX, ZETIA