BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2449873 · Received February 14, 2012

    Report

    Report Number
    1423500-2012-03502
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 25, 2012
    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). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THE CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF LOW HB (HEMOGLOBIN LOW), INCREASED TIREDNESS AND STERILE PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED LOW HB (ACTUAL VALUE 8.1). ON (B)(6) 2012, THE PATIENT'S CONCOMITANT MEDICATION (B)(6) (3000 UNITS, WEEKLY, ROUTE NOT REPORTED) WAS INCREASED TO (6000 UNITS, WEEKLY, ROUTE NOT REPORTED) FOR THE EVENT. ON (B)(6) 2012, THE PATIENT EXPERIENCED INCREASED TIREDNESS AND DECIDED TO TAKE THE NIGHT OFF FROM HIS APD REGIMEN AND PERFORMED CAPD WITH DIANEAL UNKNOWN BAG. ON (B)(6) 2012, THE PATIENT EXPERIENCED STERILE PERITONITIS AS EVIDENCED BY CLOUDY EFFLUENT WHICH DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2012, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1.6 G, STAT LOADING DOSE, IP) AND GENTAMYCIN (30 MG, STAT LOADING DOSE, IP). THE CAUSE OF THE STERILE PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS BEING EVALUATED BY THE GASTROENTEROLOGY TEAM FOR THE EVENT OF LOW HB.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL UNKNOWN BAG AND EXTRANEAL VIAFLEX