BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3833837 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17109
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE NURSE. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS THE REGISTERED NURSE (RN) TOUCHING THE PATIENT¿S PD CATHETER AND NOT WEARING A MASK DURING AN UNRELATED TEST, WHICH CAUSED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT AND WAS DISCHARGED AT A LATER DATE. THE TREATMENT FOR PERITONITIS WAS WITH UNSPECIFIED ANTIBIOTICS (DOSAGE, ROUTE, AND FREQUENCY NOT REPORTED) WHICH WERE LATER DISCONTINUED. THE PATIENT HAD RECOVERED FROM PERITONITIS. THE PD THERAPY WHICH WAS DISCONTINUED AFTER THE ONSET OF THE EVENT WAS RESTARTED AT A LATER DATE AND WAS ONGOING AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311013 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5% AND 2.5% AMBUFLEX