BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1863887 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04271
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT (AGE NOT REPORTED) COINCIDENT WITH PERITONEAL DIALYSIS (PD)THERAPIES. IN 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS WITH (B)(6). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT DID TRANSFER TO HEMODIALYSIS. IT IS UNKNOWN IF THE PD THERAPY WAS ONGOING. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE REPORTER BELIEVED THAT THE BACTERIAL PERITONITIS WITH (B)(6) 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 Other DIANEAL PD4 ULTRABAG AND EXTRANEAL VIAFLEX