BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4953406 · Received July 30, 2015

    Report

    Report Number
    1416980-2015-30765
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 8, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS MANIFESTED BY CLOUDY PD EFFLUENT COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY. THREE DAYS PRIOR TO PERITONITIS ONSET, THE PATIENT DISCONTINUED PD THERAPY AND BEGAN BACK UP HEMODIALYSIS (HD). IT WAS REPORTED THAT THE PATIENT WAS PHYSICALLY UNABLE TO PERFORM PD THERAPY DUE TO ANOTHER INDICATION. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS ¿THE PATIENT DID NOT WASH THEIR HANDS¿. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE THE PATIENT WAS TREATED FOR THE PERITONITIS WITH AN UNKNOWN INTRAVENOUS ANTIBIOTIC (DOSE AND FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RETRAINED ON ASEPTIC TECHNIQUE, THE PATIENT REMAINED ON AT LEAST TWO WEEKS OF BACK UP HD AFTER WHICH THE PATIENT WILL BE RE-EVALUATED FOR PD THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497723 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DIANEAL PD4, 1.5% & 2.5% AMBUFLEX, HOMECHOICE