BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3972637 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-24969
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS BORN ON AN UNSPECIFIED DATE IN (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH RESULTED IN THE DEVELOPMENT OF PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT DID NOT WEAR A MASK WHILE PERFORMING PD THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH INTRAPERITONEAL CEFAZOLIN (2GRAMS PER DAY) AND INTRAPERITONEAL GENTAMICIN (80 MILLIGRAM PER DAY). THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. AFTER TWELVE DAYS IN THE HOSPITAL, TREATMENT WAS DISCONTINUED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450277 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%