BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1879100 · Received October 21, 2010

    Report

    Report Number
    1423500-2010-04736
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 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. .

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THIS IS 5 OF 8 CASES REPORTED BY THE SAME REPORTER. ON (B)(6) 2010 THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFRADINE (0.25 G, ADDED IN THE PD SOLUTION) AND ON (B)(6) 2010, CEFTAZIDIME (1 G, ADDED IN THE PD SOLUTION). ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL. DIANEAL THERAPY WAS ONGOING, DOSE UNCHANGED.

    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 50 YR Hospitalization| R DIANEAL PD4 ULTRABAG