BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4529789 · Received February 20, 2015

    Report

    Report Number
    1416980-2015-06442
    Event Type
    Injury
    Date Received
    February 20, 2015
    Date of Event
    November 10, 2014
    Report Date
    January 21, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A BREACH IN ASEPTIC TECHNIQUE THAT RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE WAS UPDATED TO KDI (PREVIOUSLY REPORTED AS KDJ). THE COMMON DEVICE NAME WAS UPDATED ACCORDING TO THE CHANGE IN THE PRODUCT CODE. 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 A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS THERAPY, WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT FORGOT TO PUT ON A MINICAP AFTER DISCONNECTING FROM PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS HOSPITALIZED AND TREATED WITH VANCOMYCIN INTRAPERITONEALLY (DOSE AND FREQUENCY NOT REPORTED) FOR THE EVENT. THE PATIENT WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL AND REPORTED TO HAVE RECOVERED FROM THE PERITONITIS EVENT. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122378 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DIANEAL AMBUFLEX 1.5% AND DIANEAL AMBUFLEX 2.5%