BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3241293 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19339
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIFTEEN DAY AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE TREATMENT WITH LEVOFLOXACIN AND HEPARIN WAS DISCONTINUED. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERED FROM PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPY WAS ONGOING. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND CLOUDY EFFLUENT AS A RESULT OF THE PERITONITIS. THE PATIENT WAS TREATED WITH LEVOFLOXACIN 0.04 G IP THREE TIMES A DAY AND HEPARIN 1000 UNITS IP THREE TIMES A DAY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341788 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R POLYSACCHARIDE-IRON COMPLEX, NIFEDIPINE| DIANEAL PD2, ASPIRIN, FOLIC ACID, LOSARTAN