BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1896972 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05638
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 19, 2010
    Report Date
    October 19, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 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 NURSE FROM THE (B)(6) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH NUTRINEAL PD4 VIAFLEX, 2000ML/DAY IP (MOST RECENT LOT NUMBER 10G03G37) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS MANIFESTED AS CLOUDY EFFLUENT. REMEDIAL TREATMENT WAS STARTED THAT DAY WITH KEFLIN (CEFATOLINE) AND KEFORAL (CEFALEXIN) 500 MG, THREE TIMES/DAY. REMEDIAL THERAPY WAS DISCONTINUED THAT DAY. NUTRINEAL THERAPY CONTINUED WITHOUT CHANGE TO DOSE OR FREQUENCY. THE PATIENT USED TO MIX THE PHYSIONEAL AND NUTRINEAL SOLUTIONS TOGETHER. A SEPARATE HEATING BAG WAS USED DURING MIXING. NO DRUGS WERE ADDED TO THE PD SOLUTIONS. THE PATIENT DID NOT REUSE SUPPLIES. HE DID NOT EXPERIENCE INFECTION AT THE CATHETER SITE AND DID NOT EXPERIENCE PERITONITIS DURING THE PREVIOUS FOUR WEEKS. PER THE NURSE, THE EVENT WAS POSSIBLY RELATED TO NUTRINEAL. THE NURSE DID NOT CONSIDER EXTRANEAL AND PHYSIONEAL TO BE SUSPECT PRODUCTS. THIS IS ONE OF MULTIPLE REPORTS FROM THE SAME REPORTER/FACILITY.

    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 38 YR Required Intervention NUTRINEAL PD4 VIAFLEX, PHYSIONEAL, AND EXTRANEAL