BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2102808 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06474
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE CAUSE IS USE ERROR- POOR ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED DESCRIBED AS THE "PATIENT MADE A MISTAKE." ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. THE PATIENT BEGAN REMEDIAL THERAPY WITH CIPROFLOXACIN (100 MG, ROUTE AND FREQUENCY WERE NOT REPORTED) AND HEPARIN (1000 UNITS, IN EACH DIALYSATE BAG, IP). IT WAS UNKNOWN IF THE DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE; THEREFORE, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. NO STATEMENT OF CAUSALITY WAS REPORTED FOR THE PERITONITIS OR THE BREAK IN ASEPTIC TECHNIQUE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN (B)(6) 2011. ON AN UNKNOWN DATE, THE PATIENT'S PERITONITIS RESOLVED AND THE REMEDIAL MEDICATIONS OF CIPROFLOXIN AND HEPARIN WERE DISCONTINUED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R DIANEAL PD2 ULTRABAG