BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951795 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00227
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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. 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 CONSUMER FROM THE (B)(6) OF "PROLONG CONNECTION OF Y SET TUBE" (CODED TO PROCEDURAL COMPLICATION), BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS BACTERIAL IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE AND "PROLONG CONNECTION OF Y SET TUBE" OCCURRED. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHICH WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT (CLOUDY BAG). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 FOR THE PERITONITIS. THE CAUSES OF THE PERITONITIS WERE A BREAK IN ASEPTIC TECHNIQUE AND "PROLONG CONNECTION OF Y SET TUBE". THE PATIENT WAS TREATED WITH AN UNKNOWN ANTIBIOTIC. IT WAS UNKNOWN IF THE PD THERAPY WAS ONGOING. THE PERITONITIS WAS ONGOING AND IMPROVED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED; THEREFORE THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC AND "PROLONG CONNECTION OF Y SET TUBE" WAS UNKNOWN.

    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 10 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG| CEFAZOLIN, HEPARIN, CEFIZIDINE