BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2003229 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02548
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 10, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL AND EXTRANEAL VIAFLEX THERAPIES INTRAPERITONEALLY (IP) FOR RENAL FAILURE CHRONIC. ON (B)(6) 2011, THE PATIENT CALLED BAXTER (B)(4) TECHNICAL SERVICE TO REPORT THAT SHE HAD BEEN HOSPITALIZED FOR PERITONITIS. IT IS UNKNOWN IF THE DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. IT WAS UNKNOWN WHETHER REMEDIAL TREATMENT WAS PROVIDED OR IF THE PERITONITIS RESOLVED. NO STATEMENT OF CAUSALITY WAS REPORTED FOR THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL UNK BAG| EXTRANEAL VIAFLEX