BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3241222 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19324
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 3 YEARS AGO, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, THE PATIENT WAS PUT ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). APPROXIMATELY 6 WEEKS PRIOR TO THIS REPORT, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. IT WAS REPORTED THAT THE PERITONITIS WAS CAUSED BY THE PATIENT'S HYGIENE (DETAILS NOT PROVIDED). ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) UNSPECIFIED ANTIBIOTICS IN THE HOSPITAL FOR THE PERITONITIS. TWO DAYS AFTER BEING ADMITTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS NOT RETRAINED ON ASEPTIC TECHNIQUE, HOWEVER, THE PATIENT'S WIFE AND DAUGHTER RECEIVED TRAINING ON PROPER ASEPTIC PROCEDURES FROM THE PD CLINIC. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341296 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2.5%| DIANEAL PD4, 1.5%