BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3050892 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08949
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    December 7, 2012
    Report Date
    March 18, 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). 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 RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS DURING A STUDY COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. AS A RESULT OF THE PERITONITIS, THE PATIENT FELT ABDOMINAL PAIN AND NAUSEA. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED INTRAVENOUS (IV) LEVOFLOXACIN HYDROCHLORIDE 0.4 G, AS WELL AS ACID SUPPRESSION AND REHYDRATION TREATMENT FOR THE EVENT. ON A LATER DATE, THE PATIENT RECOVERED FROM THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148614 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R LACTATE - G 1.5% AND NIFEDIPINE