BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3083418 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10724
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 5, 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). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: TWO DAYS AFTER USING ANTIBIOTICS, THE PATIENT RECOVERED FROM THE ABDOMINAL PAIN AND THE CLOUDY EFFLUENT. SIXTEEN DAYS AFTER HOSPITALIZATION, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. THE FOLLOWING DAY, THE PATIENT STOPPED TREATMENT WITH ANTIBIOTICS AND WAS DISCHARGED FROM THE HOSPITAL. 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 COINCIDENT WITH THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THERAPY WAS ONGOING. PRIOR TO HOSPITALIZATION, THE PATIENT EXPERIENCED DIARRHEA, TENDERNESS, AND CLOUDY EFFLUENT. AS A RESULT OF THE PERITONITIS, THE PATIENT EXPERIENCED A FEVER. THE PATIENT WAS TREATED WITH VANCOMYCIN, GENTAMYCIN AND CEFAZOLIN FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE MUDDY FLUID, TENDERNESS, AND DIARRHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184803 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5%