BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3964452 · Received July 29, 2014

    Report

    Report Number
    1416980-2014-24552
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(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 EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH RESULTED IN PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT DID NOT WASH THEIR HANDS OR WEAR A MASK. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN FOR PERITONITIS. THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. THE PATIENT HAS RECOVERED FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440850 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R DIANEAL THERAPY