BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3864072 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18570
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    June 1, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PATIENT DEVELOPED PERITONITIS ON AN UNSPECIFIED DATE IN (B)(6) 2014. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED PERITONITIS ON (B)(6) 2014 (PREVIOUSLY REPORTED AS AN UNSPECIFIED DATE IN (B)(6) 2014). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, 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 THERAPY WHICH RESULTED IN THE DEVELOPMENT OF PERITONITIS. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION BUT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS INTRAPERITONEALLY (DOSE, ROUTE, AND FREQUENCY NOT REPORTED) FOR THE EVENT. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338642 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DIANEAL 1.5% AND 2.5% LOW CA SINGLEBAG| DIANEAL LOW CALCIUM| DIANEAL 1.5% AND 4.25% LOW CA ULTRABAG