BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2103481 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06533
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS IN A IN A (B)(6) PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX (IMPORTED STOCK, LOT NUMBERS NOT REPORTED) AND PHYSIONEAL, UNSPECIFIED PRODUCT (LOT NUMBERS NOT REPORTED) THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH IMPORTED EXTRANEAL VIAFLEX FROM AN UNREPORTED COUNTRY, AND PHYSIONEAL UNSPECIFIED PRODUCT, (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT AND WAS HOSPITALIZED THAT DAY. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT STARTED VANCOMYCIN, IP, FOR ONE DAY ONLY AND CEFTZIDIME FROM (B)(6) 2011 THROUGH (B)(6) 2011. SINCE THE SECOND DAY, THE PERITONEAL EFFLUENT WAS CLEAR. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH CEFAZOLINE, 150MG PER DAY IP. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERED FROM THE BACTERIAL PERITONITIS THE SAME DAY. AT THE TIME OF THIS REPORT, CEFAZOLINE TREATMENT WAS ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RE-TRAINED IN ASEPTIC TECHNIQUE; THEREFORE THE OUTCOME OF A BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. EXTRANEAL VIAFLEX AND PHYSIONEAL THERAPIES WERE ONGOING. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE BELIEVED THE BACTERIAL PERITONITIS WITH (B)(6) WAS UNRELATED TO EXTRANEAL OR PHYSIONEAL THERAPIES. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 MO Hospitalization| R PHYSIONEAL| EXTRANEAL VIAFLEX