BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1940309 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07354
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    December 12, 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. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IN (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL 2000 TWICE A DAY, NUTRINEAL PD4 UNKNOWN 2000 TWICE A DAY DURING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS FOR RENAL LUPUS ERYTHEMATOSUS. ON (B)(6) 2010, THE PATIENT DEVELOPED ASEPTIC PERITONITIS CHARACTERIZED BY PERITONEAL CLOUDY EFFLUENT. THE SAME DAY, THE PATIENT WAS TREATED WITH IP CEFAZOLIN 1GM DAILY AND IP GENTAMICIN. ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE ASEPTIC PERITONITIS AND PERITONEAL CLOUDY EFFLUENT. GENTAMICIN WAS DISCONTINUED THE SAME DAY. ON (B)(6) 2010, CEFAZOLIN WAS DISCONTINUED. EXTRANEAL VIAFLEX, NUTRINEAL PD4 UNKNOWN AND PHYSIONEAL UNKNOWN WERE ONGOING. THE REPORTING PHYSICIAN BELIEVED THE ASEPTIC PERITONITIS WAS UNRELATED TO EXTRANEAL VIAFLEX, NUTRINEAL PD4 UNKNOWN AND PHYSIONEAL UNKNOWN THERAPIES. THE REPORTING PHYSICIAN BELIEVED THE ASEPTIC PERITONITIS WAS UNRELATED TO EXTRANEAL VIAFLEX, NUTRINEAL PD4 UNKNOWN AND PHYSIONEAL UNKNOWN THERAPIES.

    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 39 YR Required Intervention EXTRANEAL 2000 TWICE A DAY, NUTRINEAL PD4 UNKNOWN| BISOPROLOL, TORASEMIDE AND CALCICARE