BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3213398 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17823
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE CAUSE OF THE PERITONITIS WAS A USE ERROR REPORTED TO BE 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, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE THAT RESULTED IN PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. ACTION TAKEN WITH THERAPY WAS UNKNOWN. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND CLOUDY EFFLUENT AS A RESULT OF THE PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH AMIKACIN (12.5 MG, ROUTE AND FREQUENCY NOT REPORTED) AND VANCOMYCIN (1 GRAM, ROUTE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314215 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R DIANEAL 1.5% AND 4.25% ULTRABAGS| AMLODIPINE AND FESO4