BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2230724 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11540
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE THE PATIENT BEGAN REMEDIAL THERAPY WITH AMIKACIN (25 MG/L, IP, FREQUENCY NOT REPORTED). PATIENT'S RELEVANT LABORATORY FINDINGS WERE REPORTED AS FOLLOWED: HEMOGLOBIN 109, HEMATOCRIT 0.325, WBC 17.5, CREATININE 6.49, BUN 40.45, SODIUM 130, AND POTASSIUM 3.1 (UNITS WERE NOT REPORTED). IT WAS NOT REPORTED WHETHER REMEDIAL THERAPY WITH AMIKACIN WAS ONGOING. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE OUTCOME FOR THE EVENT OF PERITONITIS WAS REPORTED AS ONGOING AND IMPROVED. DIANEAL PD2 THERAPY WAS ONGOING. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN BELIEVED THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD2 THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG