BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3002946 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06079
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). DIANEAL THERAPIES WERE ONGOING. DURING A CALL, THE FOLLOWING WAS REPORTED. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT STARTED TREATMENT WITH CEFAZOLIN (1GM, ONCE PER DAY, AND IP) AND FORTUM (1GM, ONCE PER DAY, AND IP) FOR PERITONITIS. THE PATIENT HAD NOT YET RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104834 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R DIANEAL PD4 1.5% AND DIANEAL PD4 2.5%