BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3892888 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20187
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS THERAPY WHICH RESULTED IN THE DEVELOPMENT OF PERITONITIS. THE CAUSE OF THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT HAD FAKE NAILS WHICH LED TO CONTAMINATION WHEN THE PATIENT WAS HANDLING THE SUPPLIES. THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS AND WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED FOR THE PERITONITIS WITH A INTRAPERITONEAL VANCOMYCIN (DOSE AND FREQUENCY UNKNOWN). THE PATIENT CATHETER WAS REMOVED AND THE HEMODIALYSIS WAS INITIATED. THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE AND DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS WITH ONGOING TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368971 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R DIANEAL 2.5% ULTRABAG