BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3140680 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13965
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH DIANEAL AND EXTRANEAL VIAFLEX THERAPIES (DOSES AND FREQUENCIES NOT REPORTED), INTRAPERITONEALLY (IP) FOR PD. ON AN UNREPORTED DATE, THE PT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT REPORTED). SUBSEQUENTLY THE PT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT THE SAME DAY. ONE DAY LATER, THE PT EXPERIENCED SEPSIS DUE TO THE PERITONITIS. TREATMENT FOR SEPSIS AND PERITONITIS INCLUDED VANCOMYCIN (ROUTE, DOSE AND FREQUENCY WAS NOT REPORTED). CONCOMITANT THERAPY WAS NOT REPORTED. FIVE DAYS LATER, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PT BEGAN HEMODIALYSIS THERAPY. THE PATIENT WAS STILL HOSPITALIZED AT THIS TIME. THE PATIENT WAS RECOVERING FROM THE SEPSIS AND PERITONITIS. THE PATIENT WILL BE RETRAINED ON PROPER ASEPTIC TECHNIQUE WHEN DIANEAL AND EXTRANEAL THERAPY IS RESTARTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241590 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R DIANEAL PD2, 2.5%, AMBUFLEX| DIANEAL PD4, 1.5%, AMBUFLEX| EXTRANEAL VIAFLEX