BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3520802 · Received December 16, 2013

    Report

    Report Number
    1416980-2013-34720
    Event Type
    Injury
    Date Received
    December 16, 2013
    Date of Event
    September 19, 2013
    Report Date
    November 20, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY TURBID DRAIN OUT SOLUTION. THE SAME DAY THE PATIENT WAS TREATED WITH CEF-4 (1 GRAM LOADING DOSE) INTRAPERITONEAL (IP), THEN 300 MG EACH BAG (4 EXCHANGES, DAILY) AND CEFAZOLIN (1 GRAM LOADING DOSE), (IP), THEN 300 MG EACH BAG (4 EXCHANGES, DAILY) FOR 3 WEEKS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. FOUR DAYS AFTER FINISHING TREATMENT THE PATIENT EXPERIENCED A SECOND PERITONITIS EVENT MANIFESTED BY STOMACHACHE AND TURBID DRAIN OUT SOLUTION. THAT SAME DAY THE PATIENT THE PATIENT WAS TREATED WITH CEF-4 (1 GRAM LOADING DOSE) INTRAPERITONEALLY (IP), THEN 300 MG EACH BAG (4 EXCHANGES, DAILY) , CEFAZOLIN (1 GRAM LOADING DOSE) (IP), THEN 300 MG EACH BAG (4 EXCHANGES, DAILY) AND HEPARIN 1,000 MICRONS/BAG FOR 7 DAYS. THE DAY AFTER FINISHING TREATMENT A TURBID DRAIN OUT SOLUTION WAS FOUND. NO LAB WORK WAS PERFORMED. THE CAUSE OF THE SECOND PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT IT WAS NOT REPORTED IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT. ON AN UNKNOWN DATE THE PATIENT HAD DISCONTINUED PD THERAPY AND HEMODIALYSIS WAS INITIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656001 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL LOW CALCIUM 1.5%