BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3023923 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07482
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED DIFFICULTY OF BREATHING AND WAS HOSPITALIZED FOR THE EVENT. ON THAT SAME DAY THE PATIENT WAS DISCHARGED FROM THE HOSPITAL DUE TO NO FUNDS, THE PATIENT WAS NOT TREATED DUE TO NO FUNDS. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE FOR THIS REPORT WAS NOT RECEIVED, THEREFORE THE PROBLEM COULD NOT BE CONFIRMED. THE CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT, COINCIDENT WITH DIANEAL THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PATIENT HAD PERITONITIS MANIFESTED AS CLOUDY EFFLUENT. ON THAT SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT, HOWEVER THE TREATMENT WAS NOT PROVIDED. TWO DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, HOWEVER THE PATIENT STILL HAD A CLOUDY EFFLUENT WHICH WAS DESCRIBED AS A HAZY DRAIN. THE PATIENT HAD NOT RECOVERED FROM THIS PERITONITIS EVENT AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125261 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization DIANEAL PD2 4.25%| DIANEAL PD2 1.5%