BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3183030 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16186
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4): ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFTAZIDIME AND CEFAZOLIN (IP, DOSES, AND FREQUENCIES WAS NOT REPORTED). THE DIALYSATE WAS CLEAR AND ABDOMINAL PAIN HAD RECOVERED. DURING ANOTHER FOLLOW-UP, ON AN UNREPORTED DATE, THE PATIENT HAD NO FEVER AND NO ABDOMINAL PAIN. THE PATIENT WAS STILL WITH HAZY DRAIN AND HAD GOOD INFLOW AND OUTFLOW. THE PATIENT STARTED AGAIN WITH ANTIBIOTICS CEFTAZIDIME (1 GM IN NIGHT DWELL IN 4 EXCHANGES) AND CEFAZOLIN (1 GM IN MORNING DWELL IN 4 EXCHANGES) FOR THE PERITONITIS. THE PATIENT RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED. THE PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE CAUSE OF PERITONITIS WAS ATTRIBUTED TO THE PRESENCE OF PETS IN THE PATIENT'S HOUSE. TREATMENT RENDERED WAS NOT REPORTED. THE OUTCOME FOR THIS PERITONITIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283246 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other DIANEAL PD2 1.5% AND DIANEAL PD2 2.5%| EPO (ERYTHROPOIETIN), FERROUS SULFATE, IMDUR| CARVEDILOL, AMLODIPINE, CLOPIDOGREL, ATORVASTATINE| ALLOPURINOL, IBERET WITH FOLIC, AND SODIUM