BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1844587 · Received September 27, 2010

    Report

    Report Number
    1423500-2010-03735
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS NOT KNOWN. THE ROOT CAUSE FOR THE PERITONITIS IS UNDETERMINED AS NO SAMPLE WAS AVAILABLE FOR EVALUATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH LOADING DOSE IP INJECTIONS OF AMIKACIN 150MG AND VANCOMYCIN 1GM. ALSO ON AN UNREPORTED DATE, THE PATIENT STARTED TREATMENT 3X/DAY WITH IP INJECTIONS OF FORTUM 500MG AND REFLIN 500MG. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND THE OUTCOME AND ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. PD THERAPY WAS ONGOING. THE REPORTER BELIEVED THE EVENT OF PERITONITIS WAS NOT RELATED TO PD THERAPY.

    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 55 YR Hospitalization| R DIANEAL PD2 ULTRABAG