BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1946287 · Received January 4, 2011

    Report

    Report Number
    1423500-2011-00025
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 14, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONEAL CLOUDY EFFLUENT AND SUSPECTED ASEPTIC PERITONITIS IN A PATIENT FOLLOWING PERITONEAL DIALYSIS (PD) THERAPY WITH EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES. THIS IS ONE OF MULTIPLE REPORTS FROM THE SAME REPORTER. ON AN UNREPORTED DATE, THE PATIENT DEVELOPED PERITONEAL CLOUDY EFFLUENT AND ASEPTIC PERITONITIS WAS SUSPECTED. IT WAS NOT REPORTED WHETHER THE PATIENT HAD AN EXIT SITE OR TUNNEL INFECTION. TREATMENT AND OUTCOME WERE NOT PROVIDED. ACTION TAKEN WITH EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG WERE NOT REPORTED. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE PERITONEAL CLOUDY EFFLUENT AND ASEPTIC PERITONITIS.

    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 77 YR Other EXTRANEAL VIAFLEX AND NUTRINEAL PD4