BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1821921 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03034
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    May 7, 2010
    Report Date
    August 9, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO LACK OF SAMPLE FOR EVALUATION AND INSUFFICIENT INFORMATION AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW COULD NOT BE PERFORMED. NO SPECIFIC PRODUCT FAILURES WERE INDICATED IN THE COMPLAINT REPORT THAT COULD CONTRIBUTE TO PERITONITIS. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM REGARDING BACTERIAL PERITONITIS IN AN (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A PROLONGED HOSPITALIZATION. WHILE HOSPITALIZED, ON (B)(6) 2010, THE PATIENT DEVELOPED BACTERIAL PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS AND HAD RECOVERED FROM THE EVENT OF BACTERIAL PERITONITIS ON AN UNKNOWN DATE. THE PHYSICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE PD SOLUTION DIRECTLY, BUT THE PHYSICIAN "COULD NOT DENY THE POSSIBILITY OF CONTAMINATION WHEN THE PD SOLUTION WAS ADMINISTERED".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R EXTRANEAL VIAFLEX