BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3231522 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18752
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. FIFTEEN DAYS PRIOR TO RECEIPT OF THIS REPORT, THE PT BEGAN TREATMENT WITH DIANEAL PD2, 1.5% ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) AND TWO DAYS LATER, THE PT BEGAN TREATMENT WITH DIANEAL PD2, 2.5% SINGLE BAG (5 LITER, FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP), FOR PD. ON AN UNREPORTED DATE, THE PT MADE A MISTAKE OF BREAK IN ASEPTIC TECHNIQUE (DETAILS NOT PROVIDED). THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DATE. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJ. VANCOMYCIN (1GM AS LOADING DOSE, IP) AND INJ. FORTUM (1GM, IP), FREQUENCIES NOT REPORTED, FOR PERITONITIS. CONCOMITANT THERAPY WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332236 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R DIANEAL PD2 , 2.5%, AMBUFLEX| DIANEAL PD2 1.5% ULTRABAG