BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3902518 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20844
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    February 12, 2012
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE FURTHER SPECIFIED AS THE PATIENT'S DOG CHEWED THROUGH THE LINE RESULTING IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. PATIENTS ARE ADVISED NOT TO HAVE ANIMALS IN THE ROOM WHEN PERFORMING THERAPY AS CONTAMINATION CAN OCCUR. A 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 PD NURSE REPORTED THE PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. ON (B)(6) 2012, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN, 2 GRAMS EVERY 4 DAYS FOR 14 DAYS AND IP TOBRAMYCIN 60 GRAMS EVERY OTHER DAY FOR 14 DAYS. ON AN UNREPORTED DATE THE PATIENT WAS RETRAINED. 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 COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS EVENT WAS REPORTED TO BE THAT THE PATIENT¿S DOG CHEWED THROUGH THE PATIENT EXTENSION SET. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS (DOSE, ROUTE, DURATION, FREQUENCY NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE EVENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381242 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention DIANEAL 1.5%, DIANEAL 2.5%, HOMECHOICE