BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3970334 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24782
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) WHICH CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTIC(S) INTRAPERITONEALLY (MEDICATION, DOSAGE, AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS EVENT. AFTER FIVE DAYS OF HOSPITALIZATION FOR PERITONITIS, THE PATIENT WAS DISCHARGED. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448266 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R DIANEAL 1.5% AND 2.5% LOW CALCIUM SINGLEBAG