BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3802951 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14974
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY PAIN, DISCOMFORT, CLOUDY EFFLUENT, AND TROUBLE WITH DRAINS DUE TO CONSTIPATION COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS. THE PATIENT WAS TREATED WITH CLINDAMYCIN (FOR A TOTAL OF 3 DAYS, DOSE, FREQUENCY, ROUTE NOT REPORTED) AND VANCOMYCIN (DOSE, FREQUENCY, ROUTE NOT REPORTED) FOR PERITONITIS. TWENTY-EIGHT DAYS AFTER THE ONSET OF PERITONITIS, THE VANCOMYCIN WAS DISCONTINUED. THE FOLLOWING DAY, THE PATIENT¿S CATHETER WAS REMOVED AND THE PATIENT WAS TEMPORARILY SWITCHED TO HEMODIALYSIS THERAPY. HOWEVER, THE PATIENT WILL CONTINUE TAKING VANCOMYCIN WHILE ON HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT¿S EFFLUENT REMAINED CLOUDY AND WAS NOT RECOVERED FROM THE PERITONITIS EVENT. PAIN/DISCOMFORT HAS DECREASED YET NOT FULLY RECOVERED. THE PATIENT RECOVERED FROM CONSTIPATION WHILE IN THE HOSPITAL. THE PATIENT WILL CONTINUE TREATMENT OF VANCOMYCIN WHILE PERFORMING HEMODIALYSIS. ADDITIONAL INFORMATION NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280802 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R BETA BLOCKER, IRON, AND CALCIUM| EXTRANEAL, NUTRINEAL 1.1%, DIANEAL 1.5%