BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3031695 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08183
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY AND THE PATIENT DEVELOPED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE, INVOLVING TOUCH CONTAMINATION. TWO WEEKS AFTER BEGINNING PD THERAPY, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND A BLOOD CLOT IN THE LEFT GROIN. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. ON AN UNKNOWN DATE THE SAME MONTH, THE PATIENT WAS TREATED FOR THE BLOOD CLOT IN THE LEFT GROIN WITH INTRAVENOUS HEPARIN AND COUMADIN (DOSE, FREQUENCY AND LOT NOT REPORTED). ON AN UNKNOWN DATE THE SAME MONTH THE PATIENT WAS TREATED FOR THE PERITONITIS WITH VANCOMYCIN (DOSE FREQUENCY AND LOT UNKNOWN). THREE DAYS AFTER BEING HOSPITALIZED, THE PATIENT WAS DISCHARGED. ON AN UNREPORTED DATE THE SAME MONTH THE PATIENT WAS RE-TRAINED IN ASEPTIC PROCEDURE FOR PD THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE BLOOD CLOT IN THE LEFT GROIN AND THE PERITONITIS. AT THE TIME OF THIS REPORT, DIANEAL THERAPY WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135088 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R DIANEAL 1.5%, LOW CALCIUM, ULTRABAG| DIANEAL 2.5%, LOW CALCIUM, ULTRABAG