BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1960534 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00568
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL UNKNOWN THERAPIES. ON (B)(6) 2010, THE PATIENT STARTED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, 2L DAILY, AND PHYSIONEAL 1.36%, 6L DAILY (LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CAPD. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT WITHOUT ABDOMINAL PAIN. THE PATIENT WAS NOT HOSPITALIZED. EXTRANEAL VIAFLEX AND PHYSIONEAL UNKNOWN THERAPIES REMAINED ONGOING. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH VANCOMYCIN 2GM IP (ACCORDING TO VANCOMYCIN TITER) AND CEFTAZIDIME 1GM IP DAILY. ON (B)(6) 2010, CEFTAZIDIME TREATMENT WAS DISCONTINUED AND VANCOMYCIN REMAINED ONGOING. THE REPORTING NURSE BELIEVED THAT THIS PERITONITIS WAS UNLIKELY TO BE RELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL THERAPIES. IN HER OPINION, PERITONITIS WAS DUE TO BREAK IN ASEPTIC TECHNIQUE. THE NURSE ADDED THAT THE PATIENT DID NOT HAVE GOOD CONDITIONS TO PERFORM PERITONEAL DIALYSIS AT HOME. THE NURSE BELIEVED THAT THE PERITONITIS WAS RELATED WITH BAD HYGIENIC MEASURES AT HOME.

    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 46 YR Required Intervention EXTRANEAL VIAFLEX AND PHYSIONEAL 1.36%