BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6100312 · Received November 14, 2016

    Report

    Report Number
    1416980-2016-17274
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    July 7, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) THERAPY EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED INDICATION. ON THE SAME DAY AS THE HOSPITALIZATION, THE PATIENT WAS ALSO FOUND TO HAVE CLOUDY DIALYSATE AND STAPHYLOCOCCUS AUREUS PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS AFTER BEING ADMITTED. THE UNSPECIFIED TREATMENT FOR PERITONITIS WAS CONTINUED POST HOSPITALIZATION BUT THE PERITONITIS DID NOT RESOLVE. THE PD CATHETER WAS REMOVED AND THE PATIENT WOULD PERFORM IN-CENTER HEMODIALYSIS UNTIL THE NEW PD CATHETER WAS PLACED. APPROXIMATELY TWO MONTHS AFTER THE ONSET, THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751150 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R DIANEAL 1.5%| DIANEAL 2.5%| DIANEAL 4.25%| EXTRANEAL