BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2003142 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02536
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 8, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AND EXTRANEAL VIAFLEX THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED STERILE PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT, AND WAS HOSPITALIZED THAT SAME DAY. THE SEVERITY FOR THE EVENT WAS REPORTED AS MODERATE. THE NURSE REPORTED THE PATIENT DENIED ANY CONTAMINATION. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY OF VANCOMYCIN 2GM, IP; CEFTAZIDIME 1GM IP; AND CIPROFLOXACIN 250MG TWICE DAILY (ROUTE WAS NOT REPORTED). THE VANCOMYCIN WAS REPEATED ON (B)(6) 2011, "AS PER UNIT PROTOCOL". ON (B)(6) 2011, THE PATIENT RECOVERED FROM THE EVENT OF STERILE PERITONITIS, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT "CURRENT REGIME WAS NOT STOPPED"; THEREFORE, DIANEAL PD4 UNKNOWN BAG, AND EXTRANEAL VIAFLEX THERAPIES WERE REPORTED AS ONGOING. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF STERILE PERITONITIS, AND THE RELATIONSHIP TO DIANEAL PD4 UNKNOWN BAG, AND EXTRANEAL VIAFLEX THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD4 UNKNOWN BAG 1.36% AND 2.27%