BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2120660 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07466
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 OF THIS INCIDENT WAS DETERMINED TO BE USE ERROR-BREAK IN ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF PATIENT NOT USING A MASK WHEN EXCHANGING DIALYSATE BAGS AND PERITONITIS IN A PATIENT (B)(6) COINCIDENT WITH DIANEAL-N-PD4 2.5 % THERAPY. IN (B)(6) 2007, THE PATIENT STARTED TREATMENT WITH DIANEAL-N-PD4 2.5 %, (6500ML, BID, IP), (LOT NUMBER, WAS NOT REPORTED), INTRAPERITONEALLY (IP) FOR RENAL FAILURE CHRONIC. ON (B)(6) 2011, THE PATIENT CALLED BAXTER (B)(4) TECHNICAL SERVICE TO REPORT THAT HE HAD EXPERIENCED A MILD PERITONITIS A "LITTLE WHILE AGO." UPON FOLLOW UP WITH THE PERITONEAL DIALYSIS NURSE, IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS "THE PATIENT NOT USING A MASK WHEN EXCHANGING DIALYSATE BAGS." ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. ON AN UNKNOWN DATE, THE PATIENT WAS STARTED ON CEFAZOLIN SODIUM AND VANCOMYCIN (DOSE, ROUTE, FREQUENCY WERE NOT REPORTED). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER RE-EDUCATION ON MASK USE WAS DONE AND THE EVENT WAS CONSIDERED RESOLVED. THE DIANEAL THERAPY WAS ONGOING AND ON (B)(6) 2011 THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE NURSE STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL N-PD4 BUT RATHER DUE TO THE PATIENT'S NOT USING A MASK WHEN EXCHANGING DIALYSATE BAGS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PATIENT NOT USING A MASK WHEN EXCHANGING DIALYSATE BAGS.

    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 Hospitalization| R DIANEAL-N-PD4 2.5 %