BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1972292 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01159
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 4, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE ROOT CAUSE FOR THIS INCIDENT IS UNDETERMINED AT THIS TIME. 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 SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONEAL CLOUDY EFFLUENT FLUID AND ABDOMINAL PAIN IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL UNKNOWN BAG THERAPY. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN BAG (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, THE PATIENT BEGAN DIANEAL UNKNOWN BAG THERAPY (DOSE AND FREQUENCY NOT REPORTED) IP FOR CAPD. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONEAL CLOUDY EFFLUENT FLUID AND MODERATE ABDOMINAL PAIN. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH GENTAMICIN 40 MG ONCE PER DAY AND AMPICILLIN 500 MG FOUR TIMES PER DAY. ON (B)(6) 2010, TREATMENT WITH GENTAMICIN WAS DISCONTINUED. THE PHYSICIAN CONSIDERED THE SEVERITY OF THE EVENTS AS MODERATE. OUTCOME FOR THE EVENTS OF PERITONEAL CLOUDY EFFLUENT FLUID AND ABDOMINAL PAIN WERE NOT REPORTED. DIANEAL THERAPY WAS REPORTED AS ONGOING. THE PATIENT WAS NOT BEING ADMINISTERED ANY CONCOMITANT MEDICATIONS. THE PHYSICIAN BELIEVED THAT THE EVENTS OF PERITONEAL CLOUDY EFFLUENT FLUID AND ABDOMINAL PAIN WERE UNRELATED TO DIANEAL 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 60 YR Required Intervention