BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3242387 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19407
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PD4 AMBUFLEX THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PD. ON AN UNREPORTED DATE, THE PT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED). THE PT EXPERIENCED PERITONITIS AND WAS NOT HOSPITALIZED FOR THE EVENT. THE PT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. AT TIME OF THIS REPORT THE PT WOULD CONTINUE ANTIBIOTICS FOR 2 MORE WEEKS (DATES NOT REPORTED). CONCOMITANT THERAPY NOT REPORTED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS AND DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343379 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DIANEAL PD4, 2.5%, AMBUFLEX, LOW CALCIUM| DIANEAL PD4, 1.5%, AMBUFLEX, LOW CALCIUM