BEUDAMED
    FDA Adverse Event Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1991439 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01978
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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 IS A REPORT BY A PHYSICIAN FROM (B)(6) OF DIALYSATE SLIGHTLY CLOUDY AND ABDOMINAL PAIN IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY (LOT NUMBER NOT REPORTED). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED SLIGHTLY CLOUDY DIALYSATE AND ABDOMINAL PAIN. REMEDIAL TREATMENT CONSISTED OF IP VANCOMYCIN (DOSE AND FREQUENCY NOT REPORTED) AND ORAL CIFLOX (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2011, THE PATIENT FORGOT TO TAKE CIFLOX. ON (B)(6) 2011, THE PATIENT WAS SEEN BY THE PHYSICIAN AND THE ABDOMINAL PAIN HAD DECREASED BUT WAS STILL PRESENT. THE OUTCOME OF THE EVENT OF DIALYSATE SLIGHTLY CLOUDY WAS NOT REPORTED. THE ACTION TAKEN WITH EXTRANEAL VIAFLEX THERAPY WAS NOT REPORTED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN BELIEVED THE EVENTS OF DIALYSATE SLIGHTLY CLOUDY AND ABDOMINAL PAIN WERE POSSIBLY RELATED TO EXTRANEAL VIAFLEX THERAPY.

    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 87 YR Required Intervention EXTRANEAL VIAFLEX