BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3841930 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17527
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE NEXT DAY AFTER THE ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN (2G, INTRAPERITONEALLY(IP), STAT) AND GENTAMICIN (40MG, IP, STAT). FIFTEEN DAYS LATER, TREATMENT WITH VANCOMYCIN WAS DISCONTINUED AND GENTAMICIN WAS CHANGED TO 66MG, IP, DAILY. CIPROFLOXACIN 500MG WAS ALSO STARTED ORALLY, BIDAILY. THE PD CATHETER WAS ALSO REMOVED AND THE PATIENT RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319229 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PHYSIONEAL 1.36%, EXTRANEAL