BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1971143 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01057
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    August 1, 2010
    Report Date
    January 7, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT 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 REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF CLOUDY EFFLUENT, BLOOD STAINED PERITONEAL EFFLUENT AND PERITONEAL EFFLUENT WITH ENRICHMENT (B)(6) IN AN PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL 40, UNKNOWN BAG THERAPIES INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, PRIOR TO INITIATING CAPD, THE PERITONEAL DIALYSIS CATHETER WAS FLUSHED WITH EXTRANEAL VIAFLEX. THE PERITONEAL EFFLUENT WAS CLOUDY AFTER 1 HOUR OF DWELL. IT WAS REPORTED THAT THE PATIENT WAS WELL, NO PAIN OR PYREXIA. THE PATIENT RECEIVED REMEDIAL THERAPY ON (B)(6) 2010 WITH VELOSEF (2000, UNITS NOT REPORTED, IP, ONCE A DAY) AND CEFTAZIDIME (2000, UNITS NOT REPORTED, IP, ONCE A DAY) FOR RAISED WHITE CELL COUNT (WCC). ON (B)(6) 2010, THE PATIENT COMPLETED TAKING VELOSEF AND CEFTAZIDIME. THE PATIENT WAS HOSPITALIZED BETWEEN (B)(6) 2010 FOR CLOUDY EFFLUENT. THE NURSE REPORTED THAT THERE WAS NO BREAK IN ASEPTIC TECHNIQUE. THE EVENT OF CLOUDY EFFLUENT RESOLVED (DATE NOT REPORTED). IT WAS NOT REPORTED IF THE EVENTS OF BLOOD STAINED PERITONEAL EFFLUENT, AND PERITONEAL EFFLUENT WITH ENRICHMENT (B)(6) RESOLVED. PHYSIONEAL 40, UNKNOWN BAG CONTINUED, ACTION TAKEN WITH EXTRANEAL VIAFLEX WAS NOT REPORTED. THE NURSE BELIEVED THAT THE EVENT OF CLOUDY EFFLUENT WAS MODERATE IN SEVERITY, HOWEVER, DID NOT REPORT ON WHETHER THE EVENT OF CLOUDY EFFLUENT WAS RELATED TO EXTRANEAL VIAFLEX OR PHYSIONEAL 40, UNKNOWN BAG THERAPIES. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE EVENTS OF BLOOD STAINED PERITONEAL EFFLUENT AND PERITONEAL EFFLUENT WITH ENRICHMENT (B)(6).

    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 19 YR Hospitalization| R EXTRANEAL VIAFLEX