BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1973406 · Received January 30, 2011

    Report

    Report Number
    1423500-2011-01275
    Event Type
    Injury
    Date Received
    January 30, 2011
    Date of Event
    May 1, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR PATIENT 1 OF 2. 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

    ON (B)(4) 2010, BAXTER RECEIVED INFORMATION FROM A NURSE REPORTING THAT THERE WERE TWO PATIENTS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010. BAXTER RECEIVED ADDITIONAL INFORMATION ON (B)(4) 2010 FROM THE NURSE WHO REPORTED THAT THIS PATIENT WHO WAS ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS COINCIDENT WITH DIANEAL ULTRA BAG THERAPY WAS IN THE HOSPITAL FROM (B)(6) 2010 FOR THIS EPISODE OF PERITONITIS. THE PATIENT CALLED THE NURSE ON (B)(6) 2010 WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT STATED AT THE TIME THAT THE PD EFFLUENT WAS CLEAR AT THE BEDTIME EXCHANGE. THE NURSE THEN INSTRUCTED THE PATIENT TO GO TO THE ER. THE PATIENT WAS ADMITTED THAT DAY. THE PATIENT WAS BEING TREATED WITH ANCEF 17500MG DAILY FROM (B)(6) 2010. ON A SUBSEQUENT REPORT RECEIVED ON (B)(4) 2010, THE NURSE REPORTED THAT THE DOCTOR WAS TOLD BY INFECTIOUS DISEASES SPECIALIST AT THE HOSPITAL THAT BOTH ORGANISMS ARE THE SAME AND FAIRLY RARE. THE NURSE REPORTED THAT THE ONLY THING THE TWO PATIENTS HAD IN COMMON WAS BOTH WERE USING 2500ML ULTRABAGS. THE NURSE COULD NOT FIND ANYTHING WRONG WITH THEIR TECHNIQUE. THE NURSE STATED THAT SHE DOES HAVE OTHER PATIENTS ON 2500ML ULTRABAGS AND THEY ARE FINE. THE DOCTOR WAS CONCERNED ABOUT PRODUCT FAILURE BECAUSE HE HAS ONLY HAD ONE PATIENT WITH PERITONITIS IN TWO YEARS AND THEN BOTH PATIENTS ARRIVED IN THE HOSPITAL ON THE SAME DAY WITH THE SAME ORGANISM. THERE WAS NO ALLEGATION AGAINST ANY BAXTER PRODUCTS AND THE CAUSE OF THE PERITONITIS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION - RENAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 2.5L 2.5% ULTRABAG