BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1933597 · Received December 21, 2010

    Report

    Report Number
    1423500-2010-07091
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 3, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    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 IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM HUNGARY OF STERILE PERITONITIS IN A (B)(6) PATIENT WHILE RECEIVING PERITONEAL DIALYSIS (PD) THERAPY. THIS IS ONE OF MULTIPLE REPORTS FROM THE SAME REPORTER. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY MUDDY DIALYSATE. AT THAT SAME TIME, THE PATIENT STOPPED USING LOT NUMBER 10I20G44, AND CHANGED TO ANOTHER LOT (NOT REPORTED). THE PATIENT WAS TREATED WITH VANCOMYCIN AND CIPROFLOXACIN (DOSE, ROUTE AND FREQUENCY WERE NOT REPORTED). ON (B)(6) 2010 AND (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY DIALYSATE AGAIN FOLLOWING USE OF DIANEAL PD1, LOT NUMBER 10I20G44 DESPITE BEING ON ANTIBIOTIC THERAPY. ON AN UNREPORTED DATE, DIANEAL PD1 LOT NUMBER 10I20G44 WAS DISCONTINUED. HOSPITALIZATION WAS NOT NECESSARY AND THE PATIENT WAS REPORTED TO BE IN "GOOD CONDITION". ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM STERILE PERITONITIS. DIANEAL PD1 THERAPY CONTINUED WITH AN UNSPECIFIED LOT NUMBER. THE REPORTER PROVIDED THE FOLLOWING CAUSALITY STATEMENT: "PERITONITIS WAS RELATED TO PD SOLUTIONS (10I20G44) AND DEVICES."

    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 57 YR Required Intervention DIANEAL PD1 1.36%